Advanced Malignancies: ARCUS ARC-12
Sponsor: ARCUS
Study: Advanced Malignancies: ARCUS ARC-12
Cancer stage: Advanced

Description: A phase 1/1b study to evaluate the safety and tolerability of AB308 in combination with AB122 in advanced malignancies

Inclusions: 

• Participants may have any pathologically confirmed solid tumor type for which no standard of care therapy exists
• or pathologically confirmed NHL who are refractory or have relapsed on prior chemotherapy regimen and who have not received or are unable to receive allogenic stem cell transplant (ASCT) or adoptive cell transfer (ACT)
• Participants may have received up to and including 5 lines of prior systemic anti-cancer therapies for advanced/recurrent and PD (an unlimited number of prior hormonal therapies) is allowed

Exclusions: 

• Treatment with systemic immunosuppressive medication
• Prior treatment with an anti-TIGIT monoclonal antibody

Prior treatment: 

• Up to and including 5 lines of prior systemic anti-cancer therapies

Purpose: 

• To evaluate the safety, tolerability, PK, pharmacodynamics, and clinical activity of AB308 (anti-TIGIT inhibitor) in combination with zimberelimab (PD-1 inhibitor)

Basic qualifications: 

Colon: NRG-GI005
Sponsor: NRG Oncology
Study: Colon: NRG-GI005
Cancer stage: Stage IIA

Description:

Inclusions: 

• Stage IIA adenocarcinoma of the colon with at least 12 lymph nodes examined at the time of surgical resection
• Appropriate for active surveillance (i.e., no adjuvant chemotherapy) at the discretion of and as documented by the evaluating oncologist based on current practice patterns
• The distal extent of the tumor must be >= 12 cm from the anal verge on pre-surgical endoscopy 
• ECOG performance status of 0 or 1

Exclusions: 

• Colon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.)
• Pathologic, clinical, or radiologic evidence of metastatic disease

Prior treatment: 

• Yes, prior surgery is required

Purpose: 

• This phase II/III trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) testing in the blood works in predicting treatment for patients with stage IIA colon cancer after surgery

Basic qualifications:

• Stage IIA adenocarcinoma of the colon with at least 12 lymph nodes examined at the time of surgical resection
• Appropriate for active surveillance (i.e., no adjuvant chemotherapy) at the discretion of and as documented by the evaluating oncologist based on current practice patterns

Advanced Malignancies: ARCUS ARC-12
Sponsor: ARCUS
Study: Advanced Malignancies: ARCUS ARC-12
Cancer stage: Advanced

Description: A phase 1/1b study to evaluate the safety and tolerability of AB308 in combination with AB122 in advanced malignancies

Inclusions: 

• Participants may have any pathologically confirmed solid tumor type for which no standard of care therapy exists
• or pathologically confirmed NHL who are refractory or have relapsed on prior chemotherapy regimen and who have not received or are unable to receive allogenic stem cell transplant (ASCT) or adoptive cell transfer (ACT)
• Participants may have received up to and including 5 lines of prior systemic anti-cancer therapies for advanced/recurrent and PD (an unlimited number of prior hormonal therapies) is allowed

Exclusions: 

• Treatment with systemic immunosuppressive medication
• Prior treatment with an anti-TIGIT monoclonal antibody

Prior treatment: 

• Up to and including 5 lines of prior systemic anti-cancer therapies

Purpose: 

• To evaluate the safety, tolerability, PK, pharmacodynamics, and clinical activity of AB308 (anti-TIGIT inhibitor) in combination with zimberelimab (PD-1 inhibitor)

Basic qualifications: 

Gynecologic: NRG-GY019
Sponsor: NRG Oncology
Study: GY019
Cancer stage: Stage II-IV

Description: A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum (NCT#04095364)

Inclusions:

• Newly diagnosed Stage II-IV ovarian cancer
• Must have undergone an attempt at maximal upfront cytoreductive surgery and bilateral salpingo-oophorectomy

Exclusions:

• May not have received neoadjuvant chemotherapy or radiotherapy and no previous hormonal therapy for the treatment of this disease

Prior treatment:

• None

Purpose:

• To examine if letrozole monotherapy/maintenance (L/L) is non-inferior to IV paclitaxel/carboplatin and maintenance letrozole (CT/L) with respect to PFS in women with stage II-IV primary low-grade serous carcinoma of the ovary or peritoneum after primary surgical cytoreduction.

Basic qualifications:

• Same as inclusion criteria

Advanced Malignancies: ARCUS ARC-12
Sponsor: ARCUS
Study: Advanced Malignancies: ARCUS ARC-12
Cancer stage: Advanced

Description: A phase 1/1b study to evaluate the safety and tolerability of AB308 in combination with AB122 in advanced malignancies

Inclusions: 

• Participants may have any pathologically confirmed solid tumor type for which no standard of care therapy exists
• or pathologically confirmed NHL who are refractory or have relapsed on prior chemotherapy regimen and who have not received or are unable to receive allogenic stem cell transplant (ASCT) or adoptive cell transfer (ACT)
• Participants may have received up to and including 5 lines of prior systemic anti-cancer therapies for advanced/recurrent and PD (an unlimited number of prior hormonal therapies) is allowed

Exclusions: 

• Treatment with systemic immunosuppressive medication
• Prior treatment with an anti-TIGIT monoclonal antibody

Prior treatment: 

• Up to and including 5 lines of prior systemic anti-cancer therapies

Purpose: 

• To evaluate the safety, tolerability, PK, pharmacodynamics, and clinical activity of AB308 (anti-TIGIT inhibitor) in combination with zimberelimab (PD-1 inhibitor)

Basic qualifications: 

Advanced Malignancies: ARCUS ARC-12
Sponsor: ARCUS
Study: Advanced Malignancies: ARCUS ARC-12
Cancer stage: Advanced

Description: A phase 1/1b study to evaluate the safety and tolerability of AB308 in combination with AB122 in advanced malignancies

Inclusions: 

• Participants may have any pathologically confirmed solid tumor type for which no standard of care therapy exists
• or pathologically confirmed NHL who are refractory or have relapsed on prior chemotherapy regimen and who have not received or are unable to receive allogenic stem cell transplant (ASCT) or adoptive cell transfer (ACT)
• Participants may have received up to and including 5 lines of prior systemic anti-cancer therapies for advanced/recurrent and PD (an unlimited number of prior hormonal therapies) is allowed

Exclusions: 

• Treatment with systemic immunosuppressive medication
• Prior treatment with an anti-TIGIT monoclonal antibody

Prior treatment: 

• Up to and including 5 lines of prior systemic anti-cancer therapies

Purpose: 

• To evaluate the safety, tolerability, PK, pharmacodynamics, and clinical activity of AB308 (anti-TIGIT inhibitor) in combination with zimberelimab (PD-1 inhibitor)

Basic qualifications: 

Lung: A151216 (ALCHEMIST Screen)
Sponsor: Alliance
Study: Lung: A151216 (ALCHEMIST Screen)
Cancer stage: Resectable NSCLC IB-IIIA

Description:

Inclusions: 

• For post-surgical patients
• Completely resected non-small cell lung cancer. Patients with squamous cell carcinoma are eligible.
• Pathologic stage IIIA, II or IB (defined as size ≥4 cm) For all patients • ECOG Performance Status 0-1 • Age ≥ 18 years
• No prior or concurrent malignancies within 5 years, except non-melanoma skin carcinoma or in situ carcinomas. A secondary primary lung cancer is considered a concurrent malignancy and would make a patient ineligible for A151216.• No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD-1/PD-L1/CTLA-4.
• Patients who have had local genotyping are eligible, regardless of the local result.
• No patients with recurrence of lung cancer after prior resection. Patient Registration Eligibility Criteria
• Pathologic stage IIIA, II, or large IB (defined as size ≥ 4cm)
• Tissue available for the required analyses (either clinical tissue block or slides and scrolls)
• In order to allow for time for central genotyping and eligibility for the ALCHEMIST treatment trial, patients must register within the following eligibility windows, depending on the adjuvant treatment approach:

1. If no adjuvant therapy, register patient within 75 days following surgery.
2. If adjuvant chemotherapy only, register patient within 225 days following surgery.
3. If adjuvant chemotherapy and radiation, register patient within 285 days following surgery.

Exclusions: 

Prior treatment: 

• No patients who have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer.

Purpose: 

• This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been removed or will be removed by surgery.

Basic qualifications:

• Completely resected (resectable) non-small cell lung cancer.
• Patients with squamous cell carcinoma are eligible.

Lung: LungMAP Screening
Sponsor: SWOG
Study: Lung: LungMAP Screening
Cancer stage: Stage IV NSCLC

Description:

Inclusions: 

• Stage IV or recurrent NSCLC
• Must have received at least one line of systemic therapy for any stage of disease (Stages I-IV) and must have progressed during or following their most recent line of therapy
• Must have adequate tissue available and a sample submitted to Foundation Medicine for biomarker profiling
• Must be willing to provide prior smoking history

Exclusions: 

• Patients with known EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS 1 gene rearrangement, or BRAF V600E mutation are not eligible

Prior treatment: 

• Prior treatment is required: must have received at least one line of systemic therapy 

Purpose: 

• Pre-screening-to-sub-study assignment will be measured among pre-screened patients and the proportion of patients assigned to a sub-study

Basic qualifications 

• Stage IV or recurrent NSCLC
• Must have received at least one line of systemic therapy for any stage of disease (Stages I-IV) and must have progressed during or following their most recent line of therapy

Lung: M14-239
Sponsor: AbbVie
Study: Lung: M14-239
Cancer stage: NSCLC

Description: Lung Luminosity pamphlet

Inclusions:   

•   Subjects must have locally advanced or metastatic NSCLC
•   Subjects must have c-Met+NSCLC
•   Subjects have an ECOG Performance Status of 0 or 1  
•   Subjects must have received no more than 2 lines of prior systemic chemotherapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the metastatic setting

Exclusions: 

• Subjects must not have a history of interstitial lung disease or pneumonitis      

Prior treatment: 

• Subjects must have received no more than 2 lines of prior systemic chemotherapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the metastatic setting   

Purpose: 

• The primary objective is to determine the overall response rate (ORR) of telisotuzumab vedotin in subjects with c-Met+ NSCLC.

Basic qualifications: 

•   Subjects must have locally advanced or metastatic NSCLC
•   Subjects must have c-Met+NSCLC

Lung: JZP712-402
Sponsor: Jazz Pharmaceuticals
Study: Lung: JZP712-402
Cancer stage: Extensive Stage Small Cell Lung Cancer

Description: Phase IV Observational Study to Collect Safety and Outcome Data in Adult Patients with Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Zepzelca

Inclusions: 

• Patient has initiated or will be receiving Zepzelca treatment in line with the Zepzelca US prescribing information

Exclusions: 

• Patients who discontinued a prior Zepzelca treatment due to adverse events

Prior treatment: 

Purpose: 

• This is a phase IV observational study designed to collect data on treatment with Zepzelca

Basic qualifications:

• The treatment decision, decision to initiate Zepzelca, and overall patient management is entirely at the investigators’ discretion and should not be impacted by the conduct of this study

Lung: E4512 (ALCHEMIST - ALK)
Sponsor: ECOG-ACRIN
Study: Lung: E4512 (ALCHEMIST - ALK)
Cancer stage: Resectable NSCLC IB-IIIA

Description:

Inclusions: 

• Age ≥ 18 years.
• Patients must have undergone complete surgical resection of their stage IB (≥ 4 cm), II, or non-squamous IIIA NSCLC and have had negative margins. N3 disease is not allowed.
• ECOG performance status 0 or 1.
• Positive for translocation or inversion events involving the ALK gene locus (e.g. resulting in EML4-ALK fusion) as determined by the Vysis Break Point FISH assay and defined by an increase in the distance between 5’ and 3’ ALK probes or the loss of the 5’ probe.
• No known interstitial fibrosis or interstitial lung disease.
• No use of medications, herbals, or foods that are known potent CYP3A4 inhibitors or inducers.
• Patients must not have any history of cancer within 5 years from randomization, with the exception of in-situ carcinomas and non-melanoma skin cancer.

Exclusions: 

Prior treatment: 

• Adjuvant treatment is allowed. No prior treatment with crizotinib or another ALK inhibitor.

Purpose: 

• This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.

Basic qualifications:

• Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization.

Lung: MK3475-867
Sponsor: Merck
Study: Lung: MK3475-867
Cancer stage: Stages I or IIA

Description: A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) with or without Pembrolizumab (MK-3475) in Participants with Medically Inoperable Stages I or IIA NSCLC (KEYNOTE-867) Trial brochure

Inclusions: 

• Has NSCLC diagnosed by histology or cytology and confirmed as Stage I or IIA                                                            
• Cannot undergo thoracic surgery due to existing medical illness  
• Is able to receive SBRT
• Has an ECOG Performance Status of 0, 1, or 2

Exclusions: 

• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor                                                                                                                               
• Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or breast.

Prior treatment: 

• No prior therapy with an anti-PD-1, anti-PD-L1, anti PD-L2 agent or CTLA-4  

Purpose:  

• To compare the Event Free Survival following administration of Stereotactic Body Radiotherapy plus pembrolizumab versus Stereotactic Body Radiotherapy plus placebo  

Basic qualifications:

• Has NSCLC diagnosed by histology or cytology and confirmed as Stage I or IIA                                                            
• Cannot undergo thoracic surgery due to existing medical illness  

Lung: 849-007
Sponsor: Mirati
Study: Lung: 849-007
Cancer stage: Metastatic or unresectable NSCLC

Description: Krystal-7 study flyer

Inclusions: 

• NSCLC (squamous or nonsquamous) with KRAS G12C mutation
• Unresectable or metastatic disease
• Not a candidate for chemoradiation for locally advanced disease

Exclusions: 

• Prior systemic treatment for locally advanced or metastatic NSCLC

Prior treatment: 

• No prior treatment allowed

Purpose: 

• To evaluate the clinical activity of the MRTX849 study drug in combination with pembrolizumab administered in the first-line treatment setting to patients having NSCLC with KRAS G12C mutation

Basic qualifications: 

• NSCLC (squamous or nonsquamous) with KRAS G12C mutation
• Unresectable or metastatic disease

Lung: 849-012
Sponsor: Mirati
Study: Lung: 849-012
Cancer stage: Advanced or metastatic disease

Description: A Randomized Phase 3 Study of MRTX849 versus Docetaxel in Patients with Previously Treated Non-Small Cell Lung Cancer with KRAS G12C Mutation. Krystal-7 study flyer

Inclusions: 

• NSCLC with KRAS G12C mutation
• Receipt of prior treatment with a platinum and immune checkpoint inhibitor containing regimen for advanced or metastatic disease

Exclusions: 

• Active brain metastases
• Prior treatment with an agent targeting KRAS G12C

Prior treatment: 

• Prior treatment with an immune checkpoint inhibitor and a platinum containing regimen required

Purpose: 

• To compare the efficacy of MRTX849 versus docetaxel in patients with NSCLC with KRAS G12C mutation

Basic qualifications:

• NSCLC with KRAS G12C mutation 
• Receipt of prior treatment with a platinum containing regimen and an immune checkpoint inhibitor

Lung: BGB-317-A1217-302
Sponsor: BeiGene
Study: Lung: BGB-317-A1217-302
Cancer stage: Previously untreated locally advanced unresectable or metastatic Non-Small Cell Lung Cancer

Description: A Phase 3, Randomized, Double-Blind Study of BGB-A1217, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non -Small Cell Lung Cancer

Inclusions: 

• NSCLC that is not eligibel for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy
• No prior systemic treatment for metastatic NSCLC
• Tumors with PD-L1 expression as centrally determined
• Measurable lesions

Exclusions: 

• Known senstizing mutation in the EGFR gene or an ALK fusion oncogene
• Active leptomeningeal disease or uncontrolled, untreated brain metastasis

Prior treatment: 

• No prior systemic treatment for metastatic NSCLC

Purpose: 

• This study compares progression-free survival and overall survival between arm A (BGB-A1217 in combination with Tislelizumab) and arm B (Pembrolizumab followed by placebo)

Basic qualifications:

Lung: NeoImmune Tech NIT-119
Sponsor: NeoImmune Tech, Inc.
Study: NIT-119
Cancer Stage: Metastatic or locally advanced NSCLC (Non-Small Cell Lung Cancer)

Description: A multicenter, open-label, single-arm Phase II study to evaluate anti-tumor efficacy and safety of NT-I7 (efineptakin alfa) in combination with Atezolizumab in subjects with previously untreated, PD-L1-expressing, locally advanced or metastatic Non-Small Cell Lung Cancer (NCT# 04984811)

Inclusions:

• Histologically or cytologically confirmed metastatic (Stage IV) or locally advanced squamous or non-squamous NSCLC.
• Subjects with locally advanced disease must have Stage III NSCLC and are not candidates for surgical resection or definitive chemoradiation.

Exclusions:

• Prior systemic anti-cancer therapy in the metastatic or locally advanced setting. Note: subjects who received prior neo-adjuvant, adjuvant chemotherapy, and/or chemoradiotherapy with curative intent for non-metastatic disease are eligible for the study if the therapy was completed at least 6 months prior to first dose of study treatment

Prior treatment: 

• Not in metastatic or locally advanced setting

Purpose:

• To assess the preliminary anti-tumor activity of NT-I7 in combination with atezolizumab

Advanced Malignancies: ARCUS ARC-12
Sponsor: ARCUS
Study: Advanced Malignancies: ARCUS ARC-12
Cancer stage: Advanced

Description: A phase 1/1b study to evaluate the safety and tolerability of AB308 in combination with AB122 in advanced malignancies

Inclusions: 

• Participants may have any pathologically confirmed solid tumor type for which no standard of care therapy exists
• or pathologically confirmed NHL who are refractory or have relapsed on prior chemotherapy regimen and who have not received or are unable to receive allogenic stem cell transplant (ASCT) or adoptive cell transfer (ACT)
• Participants may have received up to and including 5 lines of prior systemic anti-cancer therapies for advanced/recurrent and PD (an unlimited number of prior hormonal therapies) is allowed

Exclusions: 

• Treatment with systemic immunosuppressive medication
• Prior treatment with an anti-TIGIT monoclonal antibody

Prior treatment: 

• Up to and including 5 lines of prior systemic anti-cancer therapies

Purpose: 

• To evaluate the safety, tolerability, PK, pharmacodynamics, and clinical activity of AB308 (anti-TIGIT inhibitor) in combination with zimberelimab (PD-1 inhibitor)

Basic qualifications: 

DLBCL or CLL: KRT-232-2111
Sponsor: Kartos
Study: DLBCL or CLL: KRT-232-2111
Cancer stage: DLBCL or CLL

Description:

Inclusions: 

• Cohort 1 (R/R DLBCL) a) Histologically confirmed diagnosis of de novo TP53wt ABC (nonGCB) or GCB DLBCL.  Phase 2: 25 or more subjects with non-GCB and    10 or more subjects with double-expressor lymphoma will be enrolled. b) R/R DLBCL after treatment with at least 2 prior lines of systemic therapy or at least 1 prior line of systemic therapy in subjects who are ineligible for hematopoietic stem cell transplantation c) At least 1 measurable site of disease 

• Cohort 2 (R/R CLL) d) Histologically confirmed diagnosis of TP53wt CLL according to iwCLL criteria. e) Previously treated with at least 1 prior regimen according to current guidelines. f) Active disease meeting at least 1 of the iwCLL 2008 criteria for requiring treatment 

Exclusions: 

• Subjects with a history of central nervous system involvement.
• Any recent prior therapy meeting one or more of the following criteria: a) Concurrent anticancer treatment, such as chemotherapy, cytoreductive therapy, immune therapy, or cytokine therapy: i. DLBCL: Within 14 days prior to the first dose of study treatment. ii. CLL: Within 28 days prior to the first dose of study treatment
• Allogeneic stem cell transplant within the last 6 months

Prior treatment: 

• Yes, prior treatment is required

Purpose: 

• To determine the KRT-232 maximum tolerated dose and safety and tolerability of KRT-232 in combination with acalabrutinib

Basic qualifications:

• Cohort 1 (R/R DLBCL) a) Histologically confirmed diagnosis of de novo TP53wt ABC (nonGCB) or GCB DLBCL.  Phase 2: 25 or more subjects with non-GCB and    10 or more subjects with double-expressor lymphoma will be enrolled. b) R/R DLBCL after treatment with at least 2 prior lines of systemic therapy or at least 1 prior line of systemic therapy in subjects who are ineligible for hematopoietic stem cell transplantation c) At least 1 measurable site of disease 
• Cohort 2 (R/R CLL) d) Histologically confirmed diagnosis of TP53wt CLL according to iwCLL criteria. e) Previously treated with at least 1 prior regimen according to current guidelines. f) Active disease meeting at least 1 of the iwCLL 2008 criteria for requiring treatment 

T-Cell Lymphoma: IPH4102-102
Sponsor: Innate Pharma
Study: T-Cell Lymphoma: IPH4102-102
Cancer stage: Relapsed

Description: A phase Ib trial evaluating the safety and efficacy of lacutamab in patients with relapse peripheral T-cell lymphoma that express KIR3DL2

Inclusions: 

• Patients should have received at least one prior systemic therapy
• Patients should have had a complete response to first line systemic therapy and / or relapsed or progressed no sooner than 6 months after finishing first line therapy
• KIR3DL2 expression
• Presence of at least 1 target lesion

Exclusions: 

• Treatment with > 3 lines of systemic therapies prior to enrollment. Consolidation therapy
  including stem cell transplant is not considered a line of therapy

Prior treatment: 

• Patients should have received at least one prior systemic therapy

Purpose: 

• To Evaluate the safety and efficacy of lacutamab

Basic qualifications:

Advanced Malignancies: ARCUS ARC-12
Sponsor: ARCUS
Study: Advanced Malignancies: ARCUS ARC-12
Cancer stage: Advanced

Description: A phase 1/1b study to evaluate the safety and tolerability of AB308 in combination with AB122 in advanced malignancies

Inclusions: 

• Participants may have any pathologically confirmed solid tumor type for which no standard of care therapy exists
• or pathologically confirmed NHL who are refractory or have relapsed on prior chemotherapy regimen and who have not received or are unable to receive allogenic stem cell transplant (ASCT) or adoptive cell transfer (ACT)
• Participants may have received up to and including 5 lines of prior systemic anti-cancer therapies for advanced/recurrent and PD (an unlimited number of prior hormonal therapies) is allowed

Exclusions: 

• Treatment with systemic immunosuppressive medication
• Prior treatment with an anti-TIGIT monoclonal antibody

Prior treatment: 

• Up to and including 5 lines of prior systemic anti-cancer therapies

Purpose: 

• To evaluate the safety, tolerability, PK, pharmacodynamics, and clinical activity of AB308 (anti-TIGIT inhibitor) in combination with zimberelimab (PD-1 inhibitor)

Basic qualifications: 

Melanoma HuyaBio HBI-8000-303
Sponsor: HUYA Bioscience International, LLC
Study: HBI-8000-303
Cancer stage: Unresectable or Metastatic Melanoma

Description: Multicenter, Randomized, Double-Blind Phase 3 Study of HBI-8000 Combined with Nivolumab vs. Placebo with Nivolumab in Patients with Unresectable or Metastatic Melanoma Not Previously Treated with PD-1 or PD-L1 Inhibitors (NCT04674683) Melanoma pamphlet

Inclusions:

• Diagnosis of non-uveal, Stage III (unresectable), or Stage IV (metastatic) melanoma
• Known BRAF V600 mutation status or consent to BRAF V600 mutation testing before randomization

Exclusions:

• Previous treatment
• History of a cardiovascular illness
• Uncontrolled hypertension
• New, active, or progressive brain metastases

Prior treatment:

• No

Purpose:

• To compare between Test (HBI-8000 + nivolumab) and Control (placebo + nivolumab)

Basic qualifications: Same as inclusion

• Diagnosis of non-uveal, Stage III (unresectable), or Stage IV (metastatic) melanoma
• Known BRAF V600 mutation status or consent to BRAF V600 mutation testing

Pancreatic: PT049
Sponsor: Xbiotech USA Inc.
Study: Pancreatic: PT049
Cancer stage: Advanced Pancreatic Cancer

Description: A Phase I/II randomized, double-blind, placebo-controlled trial (1-BETTER) examining XB2001 (anti-IL-1? True Human antibody) in combination with ONIVYDE + 5-FU/LV (+folinic acid) in advanced pancreatic cancer

Inclusions: 

• pancreatic adenocarcinoma of exocrine pancreas that is metastatic, unresectable, or recurrent

Exclusions: 

• Evidence of brain metastases
• Prior whole brain radiation therapy

Prior treatment: 

Purpose: This trial will include 2 portions (phase 1 and phase 2):

• The first portion will be a Phase I, open label, dose escalation study to investigate the safety and tolerability of XB2001 in at least 9 subjects as measured by Dose-Limiting Toxicity (DLT), in combination with ONIVYDE + LV + 5-FU chemotherapy regimen as second or third line treatment in subjects with advanced pancreatic cancer and to determine the recommended dose for the subsequent Phase 2 study.
• The phase 2 portion will be implemented following the completion of the Phase I portion and declaration of safety with respect to the maximum tolerated dose (MTD) or the maximum dose studied if the MTD is not observed in phase I portion.

• The target enrollment in the phase 2 portion is 60 subjects which will be randomized on a 1:1 basis to XB2001 plus ONIVYDE + LV + 5-FU (Arm 1) or placebo plus ONIVYDE + LV + 5-FU (Arm 2).

Basic qualifications:

Advanced Malignancies: ARCUS ARC-12
Sponsor: ARCUS
Study: Advanced Malignancies: ARCUS ARC-12
Cancer stage: Advanced

Description: A phase 1/1b study to evaluate the safety and tolerability of AB308 in combination with AB122 in advanced malignancies

Inclusions: 

• Participants may have any pathologically confirmed solid tumor type for which no standard of care therapy exists
• or pathologically confirmed NHL who are refractory or have relapsed on prior chemotherapy regimen and who have not received or are unable to receive allogenic stem cell transplant (ASCT) or adoptive cell transfer (ACT)
• Participants may have received up to and including 5 lines of prior systemic anti-cancer therapies for advanced/recurrent and PD (an unlimited number of prior hormonal therapies) is allowed

Exclusions: 

• Treatment with systemic immunosuppressive medication
• Prior treatment with an anti-TIGIT monoclonal antibody

Prior treatment: 

• Up to and including 5 lines of prior systemic anti-cancer therapies

Purpose: 

• To evaluate the safety, tolerability, PK, pharmacodynamics, and clinical activity of AB308 (anti-TIGIT inhibitor) in combination with zimberelimab (PD-1 inhibitor)

Basic qualifications: 

All Other Cancers: CHEM-01
Sponsor: Chemo Mouthpiece
Study: All Other Cancers: CHEM-01
Cancer stage: 

Description:

Inclusions: 

• Age 18-80 years
• Planned to receive at least 2 cycles of infused stomatotoxic chemotherapy regimens such as: ï‚· CMF (cyclophosphamide (Cytoxan), methotrexate, 5-FU) ï‚· Standard AC+T regimen (doxorubicin (Adriamycin), cyclophosphamide (Cytoxan), Taxane [paclitaxel (Taxol) or docetaxel (Taxotere)]) or any combination of two or more components (e.g., ACT, TAC, TA, AT, AC) ï‚· ABVD (doxorubicin (Adriamycin), bleomycin, vinblastine, dacarbazine) ï‚· FOLFIRI (irinotecan, 5-FU, leucovorin) ï‚·
• Any other 5-FU-based regimen (excluding FOLFOX)

Exclusions: 

• Receiving any oxaliplatin-containing chemotherapy regimen, such as FOLFOX
• Concurrent radiotherapy
• Unable or unwilling to complete study assessments
• Unable or unwilling to avoid using ice chips
• Known allergy to silicone

Prior treatment: 

• Not required

Purpose: 

• To Assess the Efficacy of a Cryotherapy Device Versus Best Supportive Oral Care in Mitigating Symptoms of Oral Mucositis in Patients Receiving Chemotherapy for the Treatment of Cancer

Basic qualifications 

• Planned to receive at least 2 cycles of infused stomatotoxic chemotherapy regimens such as: ï‚· CMF (cyclophosphamide (Cytoxan), methotrexate, 5-FU) ï‚· Standard AC+T regimen (doxorubicin (Adriamycin), cyclophosphamide (Cytoxan), Taxane [paclitaxel (Taxol) or docetaxel (Taxotere)]) or any combination of two or more components (e.g., ACT, TAC, TA, AT, AC) ï‚· ABVD (doxorubicin (Adriamycin), bleomycin, vinblastine, dacarbazine) ï‚· FOLFIRI (irinotecan, 5-FU, leucovorin)
• Any other 5-FU-based regimen (excluding FOLFOX)

High risk of Ovarian Cancer Surgical Study: NRG- CC008
Sponsor: NRG Oncology
Study: Ovarian Cancer Risk: NRG- CC008
Cancer stage: None

Description: A study to compare two surgical procedures in women with BRCA1 mutations to assess reduced risk of Ovarian Cancer  

Inclusions: 

• Women 35-50 years of age, inclusive
• At least one intact ovary and fallopian tube

Exclusions: 

• A history of any prior cancer and received chemotherapy within the past 12 months
• hormonal therapy in the past 90 days
• or radiotherapy to abdomen or pelvis at any prior time                                                                                                                                                        

Prior treatment: 

• No prior treatment within the past 12 months

Purpose: 

• A study to compare two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) in women with BRCA1 mutations to assess reduced risk of Ovarian Cancer

Basic qualifications: 

• Women 35-50 years of age with a high risk of ovarian cancer with at least one intact ovary and fallopian tube undergoing surgery

WST-PZP-005 for peripheral neuropathy
Sponsor: Winsantor
Study: WST-PZP-005
Cancer stage: Stage 3 or 4

Description: A randomized, double-blind, placebo-controlled, phase 2a study of topical Pirenzepine (WST-057) or placebo for the prevention of dose limiting chemotherapy induced peripheral neuropathy in oncology patients administered Carboplatin and Paclitaxel.

Inclusions: 

• Patients scheduled to undergo chemotherapy for an advanced or metastatic (stage 3 or 4) solid tumor with carboplatin and paclitaxel for 6 cycles of treatment.

Exclusions: 

• Pre-existing history of peripheral neuropathy due to any cause other than prior chemotherapy

Prior treatment: 

• Allowed

Purpose: 

• Evaluate the efficacy of once-daily topical dosing of WST-057 by assessing intrasubject change from baseline in function using the patient reported outcomes- FACT/GOG-Ntx 13, neurotoxicity subscale and the PROMIS Physical Function Score.

Basic qualifications: 

• Patients starting treatment with Carboplatin and Paclitaxel