A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCompugen Ltd
About this trial
The goal of this clinical trial is to learn if the experimental antibody COM701 delays the progression of ovarian cancer in participants with Relapsed Platinum Sensitive Ovarian Cancer. It will also learn about the safety of COM701.
The main questions the trial aims to answer are:
* Does COM701, when used as a maintenance treatment, stop or slow the progression of ovarian cancer? * Does COM701 delay the time to needing a new anti-cancer treatment? * What side effects do participants have when taking COM701?
Participants will:
* Visit the clinic once every 3 weeks during which the study treatment will be administered intravenously * Undergo various tests and procedures to monitor general health throughout the trial including physical examinations, vital sign measurements (heart rate, blood pressure, breathing, and body temperature), weight measurements, electrocardiography (ECG), blood and urine tests and pregnancy tests if relevant. * Undergo various tests and procedures to assess disease response throughout the trial including tumor imaging by CT scans or MRI to assess the tumor, its location, and size, and the testing of a sample of tumor tissue (from a prior biopsy or a fresh biopsy if feasible, to evaluate tumor response to treatment and to measure levels of tumor markers,
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has relapsed platinum sensitive epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
Has completed at least 2 previous courses (i.e. lines) of platinum-containing therapy
For the last chemotherapy course prior to being randomized into the study, must have had a minimum of 4 cycles of a platinum containing regimen and achieved a 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 in writing, bevacizumab or PARP inhibitor therapy.
Disqualifiers
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 any other check point inhibitors
Presence of radiographic or biopsy proven liver metastases at the beginning or completion of current line of platinum-based chemotherapy.
Trial design
Design model
Parallel
Treatments tested in this trial
COM701
DrugCOM701 will be administered via intravenous (IV) infusion once every 3 weeks.
Normal Saline
DrugSaline will be administered via intravenous (IV) infusion once every 3 weeks
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: COM701Experimental treatment 1 intervention
Group B: Normal SalinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the effect of COM701 as a single agent on progression free survival when administered as a maintenance regimen in participants with relapsed PSOC
Progression free survival in COM701-treated participants compared to placebo-treated participants
Time frame
From the date of randomization until the date of disease progression, or date of death from any cause whichever occurs first, assessed up to 2 yearsSecondary outcomes
1
To evaluate the safety and tolerability of the COM701 as a single agent when administered as a maintenance regimen in participants with relapsed PSOC
Number of participants with adverse events in the COM701 treatment arm compared to the placebo treatment arm
Time frame
From randomization up to 90 days post last cycle of study treatment (each cycle is 3 weeks; study treatment may continue up to 2 years).2
To evaluate the effect of COM701 as a single agent on other efficacy endpoints when administered as a maintenance regimen in participants with relapsed PSOC
Time to the initiation of a new anti-cancer treatment in COM701-treated participants compared to placebo-treated participants
Time frame
From date of randomization until the date of the initiation of a new anti-cancer treatment, or date of death from any cause whichever occurs first, assessed up to 2 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov