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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 approximately 2 year.
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective.
Who is the study for?
This trial is for adults with certain advanced solid tumors, including lung, ovarian, endometrial, breast (specifically triple-negative), and colorectal cancers that are not responding to standard treatments. Participants should be in good physical condition (ECOG 0-1) and have at least one measurable tumor lesion. They must not have active autoimmune diseases or significant heart issues.Check my eligibility
What is being tested?
The study is testing COM701 alone and alongside Opdivo (Nivolumab) to evaluate safety, tolerability, and initial effectiveness against various advanced cancers. It's a Phase 1 trial where doses will gradually increase to find the optimal safe amount before expanding into larger groups.See study design
What are the potential side effects?
Potential side effects may include typical immune therapy reactions like inflammation of organs or tissues, fatigue, possible infusion-related reactions such as fever or chills, lung issues like pneumonitis, and possibly exacerbation of pre-existing autoimmune conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 2 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDFE) (COM701 monotherapy and in combination with nivolumab).
Incidence of subjects with Adverse Events (AEs) as per CTCAE v4.03 and Dose-Limiting Toxicities (DLTs).
Secondary outcome measures
Incidence of subjects with Anti-COM701 antibody.
Overall Response Rate as per RECIST v1.1
Trial Design
4Treatment groups
Experimental Treatment
Group I: P1b (Combination Cohort Dose Expansion).Experimental Treatment1 Intervention
COM701 administered IV every 4 weeks in combination with Opdivo (Nivolumab) 480 mg administered IV every 4 weeks. Cohort expansion in subjects with the following select tumor types (Breast, Ovarian, Endometrial and Colorectal cancer).
Group II: P1a Arm B (Combination Dose Escalation).Experimental Treatment1 Intervention
COM701 sequential dose escalation administered IV every 3 weeks in combination with Opdivo (Nivolumab) 360mg administered IV every 3 weeks and COM701 administered IV every 4 weeks in combination with Opdivo (Nivolumab) 480mg administered IV every 4 weeks.
Group III: P1a Arm A (Monotherapy Expansion).Experimental Treatment1 Intervention
COM701 monotherapy administered IV every 4 weeks. Cohort expansion in subjects with the following select tumor types (NSCLC, Breast, Ovarian, Endometrial and Colorectal cancer).
Group IV: P1a Arm A (Monotherapy Dose Escalation).Experimental Treatment1 Intervention
COM701 monotherapy sequential dose escalation administered IV every 3 weeks and a Cohort IV every 4 weeks. Up to 8 dose escalation cohorts may be evaluated until a maximum tolerated dose or recommended phase 2 dose is identified.
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Who is running the clinical trial?
Compugen LtdLead Sponsor
2 Previous Clinical Trials
210 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,374 Total Patients Enrolled
COM701 Study DirectorStudy DirectorCompugen USA, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a heart attack or unstable chest pain in the last 6 months.My advanced cancer has no more standard treatments available or I cannot undergo them.I am fully active or can carry out light work.I have received treatments like anti-PD-1 or anti-CTLA-4 before.My endometrial cancer has returned or worsened after platinum-based chemotherapy.I stopped immunotherapy due to an immune-related side effect.My ovarian cancer returned or worsened after treatment including surgery and drugs.My lung cancer is advanced or has come back, and I've had treatments like platinum or targeted therapy.My colorectal cancer is microsatellite stable and has a KRAS mutation.I have at least one tumor that can be measured for changes.My cancer is advanced, and I've tried all standard treatments or can't have them.I have not needed systemic therapy for an autoimmune disease in the last 2 years.I have lung inflammation or disease causing symptoms.I have brain metastases that are either untreated or causing symptoms.I have received treatments like anti-PD-1 or anti-CTLA-4 before.My breast cancer is triple-negative and has not responded to previous treatments including an anthracycline, a taxane, or a PARP inhibitor.I have at least one tumor that can be measured and tracked over time.My breast cancer is triple-negative and has not responded to previous treatments including an anthracycline, a taxane, or a PARP inhibitor.My endometrial cancer has returned or worsened after platinum-based chemotherapy.My ovarian cancer returned or worsened after treatment including surgery and drugs.My NSCLC has worsened or returned after treatment including platinum or targeted therapy.I am fully active or can carry out light work.It seems like there might be an incomplete phrase. Could you please provide more context or clarify the criterion?My cancer type is eligible for a specific treatment study.My colorectal cancer is microsatellite stable and has a KRAS mutation.
Research Study Groups:
This trial has the following groups:- Group 1: P1a Arm A (Monotherapy Expansion).
- Group 2: P1b (Combination Cohort Dose Expansion).
- Group 3: P1a Arm A (Monotherapy Dose Escalation).
- Group 4: P1a Arm B (Combination Dose Escalation).
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.
What adverse effects has COM701 been associated with?
"As this is a Phase 1 trial, there is only minimal evidence regarding COM701's safety and efficacy. Thus, our team at Power estimates its risk to be low, with a score of 1."
Answered by AI
What maladies is the medication COM701 typically used to ameliorate?
"COM701 is an efficient treatment option for malignant neoplasms, unresectable melanomas, and squamous cell carcinoma."
Answered by AI
What is the geographic scope of this experiment?
"Patients may enroll in this clinical trial at numerous sites, including the University of California Los Angeles (UCLA) located in Los Angeles, CA, The University of Chicago Medical Center located in Chicago, IL and The University of Tennessee WEST Cancer Center situated in Memphis TN. Additionally there are 11 other enrolment locations available."
Answered by AI
What additional research has been conducted with COM701?
"COM701 was initially explored by researchers at Local Institution back in 2012, and there have been 250 completed studies since then. Currently, 717 active trials are recruiting participants with many of them being held in Los Angeles."
Answered by AI
What is the aggregate number of participants enrolled in this research program?
"This trial requires a total of 140 participants who meet the pre-determined eligibility requirements. People can join this research project at various locations including UCLA in Los Angeles, CA and University of Chicago Medical Center in Illinois."
Answered by AI
Is this a pioneering effort in the medical field?
"Currently, there are 717 active studies of COM701 in 49 nations and 2356 cities. Ono Pharmaceutical Co. Ltd initiated the first trial with 659 participants back in 2012. Since then, a total of 250 have been concluded."
Answered by AI
Is this research initiative currently seeking participants?
"According to clinicaltrials.gov, this trial is still accruing participants after being first posted on September 6th 2018 and then last edited on January 25th 2022."
Answered by AI
Who else is applying?
What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
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