Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
FEMALE
ID06888921

An Adaptive Clinical Platform Trial to Evaluate the Safety and Efficacy of COM701 as Monotherapy or Combination Therapy as Maintenance Therapy in Participants With Relapsed Platinum Sensitive Ovarian Cancer (PSOC)

Led by Compugen Ltd · Updated on 2026-04-01

60

Participants Needed

28

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the experimental antibody COM701 to see if it can delay the progression of relapsed platinum sensitive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. The trial aims to find out if COM701, given as maintenance treatment, can slow disease progression, delay the need for new anti-cancer treatments, and to understand its safety profile in participants who have had prior platinum-containing therapies. This trial is a randomized, double-blind, placebo-controlled study where participants have a 67% chance to receive COM701 and a 33% chance to receive a placebo. The treatment is given through intravenous infusion once every three weeks. The study includes multiple sub-studies, with initial focus on COM701 alone and later evaluation of COM701 combined with other anti-cancer drugs as maintenance therapy. Participants will visit the clinic every three weeks for treatment infusion and undergo various health checks including physical exams, vital signs, ECG, blood and urine tests, and pregnancy tests if applicable. Disease response is monitored through tumor imaging by CT or MRI scans and analysis of tumor tissue samples. The main outcome is progression-free survival over up to two years, with safety monitored during and up to 90 days after treatment. The study duration and follow-up depend on individual participant progress.

CONDITIONS

Brief Title

A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Has relapsed platinum sensitive epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
  • Has completed at least 2 previous courses of platinum-containing therapy
  • Has had a minimum of 4 cycles of platinum-containing chemotherapy in last course with partial or complete tumor response
  • Has received prior maintenance therapy with bevacizumab or a PARP inhibitor if eligible and is not a candidate for or has declined these therapies
  • Has recovered from toxicities of prior chemotherapy or other therapy to grade 1 or less except alopecia and neuropathy recovered to grade 2 or less
Not Eligible

You will not qualify if you...

  • Has had 4 or more lines of cytotoxic chemotherapy in total
  • Is being treated with immunosuppressive doses of systemic medications such as steroids within 2 weeks before study drug administration
  • Has had prior treatment with PD-1, PD-L1, anti-PVRIG, TIGIT or other checkpoint inhibitors
  • Has radiographic or biopsy proven liver metastases at the start or end of current platinum chemotherapy
  • Has had drainage of ascites during last 2 cycles of chemotherapy or after completion
  • Has had bowel obstruction in the 6 weeks prior to randomization
  • Has active central nervous system metastases or carcinomatous meningitis/leptomeningeal carcinomatosis
  • Has active hepatitis B, hepatitis C, or HIV infection
  • Has active uncontrolled bacterial, fungal, or viral infection requiring systemic treatment
  • Has received a live viral vaccine within 30 days before study start or requires live vaccine during study
  • Has history of severe allergic or hypersensitivity reactions to human or humanized monoclonal antibodies or excipients
  • Has serious or unstable systemic disorders
  • Has any condition increasing risk or interfering with study results as judged by investigator
  • Has participated in another clinical study with investigational agent or device within 4 weeks prior to first study dose
  • Is pregnant, breastfeeding, or planning pregnancy during the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 2 years

Participants receive COM701 or placebo via intravenous infusion once every 3 weeks as maintenance therapy.

Infusions every 3 weeks

Follow-up

Duration - Up to 90 days post-treatment

Participants are monitored for safety and treatment effects up to 90 days after the last study treatment cycle.

Visits as needed for safety monitoring

Trial Site Locations

Total: 28 locations

1

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States, 30912

Actively Recruiting

2

The University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Actively Recruiting

3

Northwestern Memorial Hospital

Warrenville, Illinois, United States, 60555

Actively Recruiting

4

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

5

Corewell Health

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center- Main Campus

New York, New York, United States, 10065

Actively Recruiting

7

University of Rochester Medical Center

Rochester, New York, United States, 14642

Actively Recruiting

8

Levine Cancer Institute

Charlotte, North Carolina, United States, 28204

Actively Recruiting

9

Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run

Hilliard, Ohio, United States, 43026

Actively Recruiting

10

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

11

UPMC Magee- Womens Hospital

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

12

Avera Cancer Institute

Sioux Falls, South Dakota, United States, 57105

Actively Recruiting

13

West Cancer Center

Germantown, Tennessee, United States, 38138

Withdrawn

14

UVA Comprehensive Cancer Center

Charlottesville, Virginia, United States, 22903

Actively Recruiting

15

Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz

Besançon, France, France, 25000

Actively Recruiting

16

Oncopole Claudius Regaud

Toulouse, France, France, 31059

Actively Recruiting

17

Centre Oscar Lambret

Lille, France, 59000

Actively Recruiting

18

Institut Paoli-Calmettes

Marseille, France, 13009

Actively Recruiting

19

Hospices Civils de Lyon- Centre Hospitalier Lyon Sud

Pierre-Bénite, France, 69310

Actively Recruiting

20

Centre Eugene Marquis

Rennes, France, 35042

Actively Recruiting

21

Institut de Cancerologie de l'Ouest- Site Rene Gauducheau

Saint-Herblain, France, 44805

Actively Recruiting

22

Gustave Roussy

Villejuif, France, 94800

Actively Recruiting

23

Assuta Medical Center

Ashdod, Israel, 7747629

Actively Recruiting

24

Rambam Health Care Campus

Haifa, Israel, 3109601

Actively Recruiting

25

The Edith Wolfson Medical Center

Holon, Israel, 5822012

Actively Recruiting

26

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

Actively Recruiting

27

Hadassah, University Hospital Ein Kerem

Jerusalem, Israel, 9112001

Actively Recruiting

28

The Chaim Sheba Medical Center

Ramat Gan, Israel, 5265601

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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