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Endometrial NeoplasmsPhase 1/2NCT04570839

COM701 in Combination With BMS-986207 and Nivolumab in Subjects With Advanced Solid Tumors.

A Phase 1/2 study testing COM701 in combination with BMS-986207 and nivolumab. in people with Endometrial Neoplasms and Ovarian Cancer, run by Compugen Ltd at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase 1/2 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM701 in combination with BMS-986207 and nivolumab in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Endometrial Neoplasms, Ovarian Cancer, Solid Tumor
What is being tested?
COM701 in combination with BMS-986207 and nivolumab.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
9 sitesUnited States
Study dates
31 Aug 2020to 15 May 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy and has exhausted all available standard therapy or is not a candidate for the available standard therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • During dose escalation - Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti- CTLA-4, OX-40, CD137, etc., are eligible.
  • During cohort expansion: All subjects must have measurable disease as defined by RECIST v1.1.
  • Expansion Cohorts:
  • Cohort 1 (subjects with advanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma)
Show all 17Show fewer
  • Subject must have platinum refractory/resistant ovarian cancer defined as refractoriness to platinum-containing regimen or disease recurrence < 6 months after completion of a platinum-containing regimen
  • Cohort 2 (endometrial cancer cohort)
  • Subjects with locally advanced or metastatic microsatellite stable endometrial cancer with disease recurrence or progression during or after prior therapy that included platinum-based chemotherapy.
  • Subjects must have documented MSS status by an approved test e.g. genomic testing, IHC for mismatch repair proficient.
  • Subjects must have received no more than 2 prior systemic cytotoxic therapies; there are no limits to the number of prior endocrine or antiangiogenic regimens
  • Cohort 3 (basket cohort, excludes tumor types in cohorts 1 and 2)
  • Tumor types with high expression of PVRL2 (determined by central testing).
  • Cohort 4 (Head and Neck cancer)
  • Histologically confirmed recurrent or metastatic HNSCC (oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, paranasal sinus, nasopharyngeal)
  • Cohort 4a - IO naïve. Eligible subjects can be systemic therapy naïve (frontline) or platinum failure.
  • Cohort 4b - IO failure. No limitations on the number of prior lines of systemic therapy.

Who cannot join

  • Active autoimmune disease requiring systemic therapy in the last 2 years prior to the first dose of COM701.
  • Symptomatic interstitial lung disease or inflammatory pneumonitis.
  • History of immune-related events that lead to immunotherapy treatment discontinuation.
  • Untreated or symptomatic central nervous system (CNS) metastases.
  • Cohort 1: Prior therapy with an anti-PD-1/PD-L1/2, COM701 (or any inhibitor of PVRIG), anti-TIGIT antibody, anti-CTLA-4 antibody, anti-OX-40 antibody, anti-CD137 antibody.
  • Cohort 2: Prior therapy with COM701 (or any inhibitor of PVRIG) or anti-TIGIT antibody. Subjects with MSI-H endometrial cancer are ineligible.
  • Cohort 3: Prior therapy with COM701 (or any inhibitor of PVRIG) or anti-TIGIT antibody are ineligible.
  • Cohort 4: Subjects who have received prior therapy with COM701 (or any inhibitor of PVRIG), anti-TIGIT antibody, anti-CTLA-4 antibody, anti-OX-40 antibody, anti-CD137 antibody. Subjects in cohort 4a must be IO-naïve.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Johns Hopkins University Oncology Center.

    Baltimore, Maryland, 21231

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • START Midwest.

    Grand Rapids, Michigan, 49503

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • The University of Tennessee WEST Cancer Center.

    Memphis, Tennessee, 38138

  • Columbia University

    New York, New York, 10032

  • University of Pittsburgh Cancer Center.

    Pittsburgh, Pennsylvania, 15232

  • The START Center for Cancer Care.

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 1/2 Study Evaluating the Safety, Tolerability and Preliminary Antitumor Activity of COM701 in Combination With BMS-986207 (Anti-TIGIT Antibody) and Nivolumab in Subjects With Advanced Solid Tumors.

This is a phase 1/2 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM701 in combination with BMS-986207 and nivolumab in patients with advanced solid tumors.

Read the detailed description

This phase 1/2 study evaluates the safety/tolerability, pharmacokinetics and preliminary antitumor activity of COM701 an inhibitor of poliovirus receptor related immunoglobulin domain containing (PVRIG) in combination with BMS-986207 (an inhibitor of TIGIT) and nivolumab in subjects with advanced solid tumors. The study will consist of 2 parts (part 1 - dose escalation and part 2 - dose expansion).

Part 1: escalating doses of COM701 will be combined with fixed doses of BMS-986207 and nivolumab. Upon completion of dose escalation a recommended dose of COM701 in combination with BMS-986207 and nivolumab (3-drug combination) will be determined.

Part 2: subjects will be administered the recommended dose of COM701 in combination with BMS-986207 and nivolumab. Subjects will be enrolled into one of three cohorts based on their cancer type.

Cohort 1: subjects with platinum resistant/refractory ovarian cancer, primary peritoneal or fallopian tube cancer will receive study treatment with the 3-drug combination.

Cohort 2: subjects with MSS- endometrial cancer will receive study treatment with the 3-drug combination.

Cohort 3 (Basket cohort): subjects with tumors that have high expression of a biomarker (PVRL2) will receive study treatment with the 3-drug combination. Subjects with tumor types in cohorts 1, 2 and 4 will not be enrolled into this cohort.

Cohort 4: subjects with HNSCC. This cohort will enroll subjects who have received treatment with an immune checkpoint inhibitor or subjects who have received treatment with chemotherapy but not an immune checkpoint inhibitor. All subjects enrolled in this cohort will receive study treatment with the 3-drug combination.

Being tested
COM701 in combination with BMS-986207 and nivolumab.
Keywords
TIGIT, PVRIG, checkpoint inhibitor, Immune checkpoint, Immuno-oncology, CD226, CD112, CD155, Solid tumor, Ovarian cancer, Endometrial cancer, PVRL2, Basket study, Opdivo, DNAM
Medical subject headings
Endometrial Neoplasms, Ovarian Neoplasms, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COM701 in combination with BMS-986207 and nivolumab.Drug

    Study treatment with the 3 drug combination (COM701 in combination with BMS-986207 and nivolumab).

Study groups in NCT04570839
Study groupRoleWhat they receive
Dose Escalation Cohorts.ExperimentalUp 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.
Receives: Drug: COM701 in combination with BMS-986207 and nivolumab.
Cohort 1 Expansion Cohort A (ovarian cancer)ExperimentalSingle 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.
Receives: Drug: COM701 in combination with BMS-986207 and nivolumab.
Cohort 2 Expansion Cohort (endometrial cancer).ExperimentalSingle 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.
Receives: Drug: COM701 in combination with BMS-986207 and nivolumab.
Cohort 3 Expansion Cohort (basket cohort - high PVRL2 tumors).ExperimentalSingle 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.
Receives: Drug: COM701 in combination with BMS-986207 and nivolumab.
Cohort 4 Expansion Cohort (Head and Neck cancer).ExperimentalTwo 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.
Receives: Drug: COM701 in combination with BMS-986207 and nivolumab.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of subjects with adverse events on the study.

    The proportion of subjects with any adverse event (AE) per CTCAE v5.0.

    Measured: 2 years.

  2. 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 meeting the criteria of dose-limiting toxicities (DLTs) in the 1st 28 days of the 1st cycle of study treatment during dose escalation.

    Measured: Within the DLT window (1st 28 days) of the 1st cycle during dose escalation.

  3. The recommended dose for expansion (RDFE) of the combination.

    The dose of COM701 in combination with BMS-986207 and nivolumab for the expansion cohort.

    Measured: 2 years.

  4. The Area under the curve of COM701 in subjects receiving the 3-drug combination.

    The PK profile of COM701 in combination with BMS-986207 and nivolumab.

    Measured: 2 years.

Secondary outcomes (1)

  1. The objective response rate of subjects enrolled in cohorts 1-4.

    Objective response rate per RECIST v1.1.

    Measured: 3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2020
  2. Study start31 Aug 2020
  3. Primary completion15 May 2024
  4. Study completion15 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Sequential dose escalation, followed by an expansion cohort upon determination of the recommended dose for expansion (RDFE) of COM701 in combination with BMS-986207 and nivolumab.
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04570839
Sponsor's protocol ID
CPG-03-101.
Status last verified
Jul 2024
First submitted
18 Sep 2020
Last updated
18 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing COM701 in combination with BMS-986207 and nivolumab. in people with Endometrial Neoplasms and Ovarian Cancer, run by Compugen Ltd at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of subjects with adverse events on the study. (time frame: 2 years.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04570839.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.

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