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COM701 + BMS-986207 + Nivolumab for Solid Tumors
Phase 1 & 2
Waitlist Available
Research Sponsored by Compugen Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years.
Awards & highlights
Study Summary
This trial is testing a new cancer drug, COM701, to see if it is safe and effective when used with two other drugs, BMS-986207 and nivolumab.
Who is the study for?
This trial is for adults with advanced solid tumors who've tried all standard treatments or can't use them. They should be fairly active and healthy (ECOG 0-1). Specific groups include certain ovarian, endometrial, and head & neck cancer patients. People with recent autoimmune treatment, lung issues, untreated brain metastases, or specific prior immunotherapies are excluded.Check my eligibility
What is being tested?
The study tests COM701 combined with BMS-986207 and nivolumab to see if they're safe and effective against advanced solid tumors. It's an early-phase trial that gradually increases doses before expanding to more participants based on their type of cancer.See study design
What are the potential side effects?
Potential side effects may include typical immune therapy reactions like inflammation in various organs, skin rashes, fatigue, flu-like symptoms, digestive problems and potential worsening of pre-existing autoimmune diseases.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Area under the curve of COM701 in subjects receiving the 3-drug combination.
The proportion of subjects with adverse events in the 1st cycle during dose escalation within the DLT window (28 days).
The proportion of subjects with adverse events on the study.
+1 moreSecondary outcome measures
The objective response rate of subjects enrolled in cohorts 1-4.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Dose Escalation Cohorts.Experimental Treatment1 Intervention
Up to 5 sequential dose escalation cohorts of COM701 in combination with fixed doses of BMS-986207 and nivolumab. All study drugs will be administered IV every 4 weeks until a maximum tolerated dose or recommended dose for expansion is identified.
Group II: Cohort 4 Expansion Cohort (Head and Neck cancer).Experimental Treatment1 Intervention
Two arms: subjects with head and neck cancer. Equal number of subjects in each of the 2 arms. One arm will enroll subjects who have not previously received treatment with an immune checkpoint inhibitor, the other arm will enroll subjects who have received prior treatment with an immune checkpoint inhibitor.
All subjects will receive study treatment with COM701 in combination with BMS-986207 and nivolumab. All study drugs will be administered IV every 4 weeks.
Group III: Cohort 3 Expansion Cohort (basket cohort - high PVRL2 tumors).Experimental Treatment1 Intervention
Single arm: subjects with tumor types with high expression of PVRL2 will receive study treatment with COM701 in combination with BMS-986207 and nivolumab. All study drugs will be administered IV every 4 weeks.
Group IV: Cohort 2 Expansion Cohort (endometrial cancer).Experimental Treatment1 Intervention
Single arm: subjects with MSS-endometrial cancer will receive study treatment with COM701 in combination with BMS-986207 and nivolumab. All study drugs will be administered IV every 4 weeks.
Group V: Cohort 1 Expansion Cohort A (ovarian cancer)Experimental Treatment1 Intervention
Single arm: subjects with platinum resistant/refractory epithelial ovarian cancer, primary peritoneal or fallopian tube cancer will be randomized to receive study treatment with COM701 in combination with BMS-986207 and nivolumab. The study drugs will be administered IV every 4 weeks.
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Who is running the clinical trial?
Compugen LtdLead Sponsor
2 Previous Clinical Trials
250 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,645 Previous Clinical Trials
4,130,899 Total Patients Enrolled
Lead COM701 ClinInfoStudy DirectorCompugen Ltd
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I stopped immunotherapy due to an immune-related side effect.I have brain metastases that are either untreated or causing symptoms.My ovarian cancer did not respond well to platinum-based treatment.I have had prior treatment with COM701 or similar drugs but do not have MSI-H endometrial cancer.I am fully active or can carry out light work.If you are part of the group that is getting bigger, your disease must be able to be measured using specific guidelines.My advanced cancer has no more standard treatments available or I cannot receive them.I have not needed systemic therapy for an autoimmune disease in the last 2 years.I have not been treated with COM701 or any anti-TIGIT antibody.I have lung inflammation or disease causing symptoms.I have previously been treated with specific immune-targeting cancer therapies.I have previously been treated with specific immune therapies.I have been treated with specific immune therapies but haven't received any other immunotherapy.For participants in the fourth group with head and neck cancer, the cancer must be confirmed to have come back or spread. This includes cancers in the mouth, throat, voice box, and other related areas. Participants in subgroup 4a must not have received any immunotherapy before, while those in subgroup 4b may have had previous immunotherapy.I have endometrial cancer that is not responding to platinum-based treatment and is microsatellite stable.My tumor has high levels of PVRL2, not including types from other specific groups.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2 Expansion Cohort (endometrial cancer).
- Group 2: Cohort 3 Expansion Cohort (basket cohort - high PVRL2 tumors).
- Group 3: Cohort 4 Expansion Cohort (Head and Neck cancer).
- Group 4: Dose Escalation Cohorts.
- Group 5: Cohort 1 Expansion Cohort A (ovarian cancer)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this clinical experiment for participants?
"Affirmative. According to the data hosted on clinicaltrials.gov, this trial that was initially posted on August 31st 2020 is actively seeking participants for its study population of 100 people across 9 different medical centers."
Answered by AI
How many clinics in the United States are currently participating with this research endeavor?
"The clinical trial is presently gathering patients from 9 different locations, with major sites located in Chicago, Boston and Memphis. To limit the necessary travel for prospective participants, it's prudent to select a site close by."
Answered by AI
Are there any documented instances of COM701, BMS-986207 and nivolumab being studied together in a clinical setting?
"There are currently 718 active clinical trials for COM701 when combined with BMS-986207 and nivolumab, 82 of which are in their final phase. The research is being conducted globally at 40285 locations, many of them centered around Basel BE."
Answered by AI
Is this study a pioneering effort in its field?
"There are currently 718 active studies involving COM701, BMS-986207 and nivolumab being conducted in over 2356 cities across 49 nations. The inaugural trial of this drug combination was commissioned by Ono Pharmaceutical Co. Ltd back in 2012 and included 659 participants who successfully completed the Phase 1 & 2 clinical testing process. Over the past 9 years, a total of 250 trials have been concluded for these substances."
Answered by AI
How has the mixture of COM701, BMS-986207 and nivolumab been utilized therapeutically?
"The therapeutic combination of COM701, BMS-986207 and nivolumab is chiefly used to treat malignant neoplasms. However, the cocktail may also benefit those with metastatic esophageal adenocarcinoma or unresectable melanoma/squamous cell carcinoma."
Answered by AI
What is the aggregate number of individuals participating in this research?
"Compugen Ltd, the sponsor of this trial, requires 100 compliant patients. These individuals will be recruited from two different sites in America: University of Chicago Medical Center and Massachusetts General Hospital."
Answered by AI
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