A Phase 1/2 interventional study of COM701 in combination with BMS-986207 and nivolumab. in Endometrial Neoplasms, Ovarian Cancer and Solid Tumor, sponsored by Compugen Ltd. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-18.
Sponsored by Compugen Ltd · Phase 1/2, Interventional, and Treatment
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Among 714 studies in Endometrial Neoplasms with a site in United States — 197 open to participants now, 287 under way, 22 of them phase 3. Endometrial Neoplasms · United States.
Among the 714 studies in Endometrial Neoplasms with a site in United States, this one is the 339th largest by enrollment of the 590 interventional ones that give a count, is one of 42 that started in 2020, is one of 85 in phase 1/2, and was the 414th registered.
1,426 studies on the registry are indexed under Endometrial Neoplasms; 471 are open to participants now.
Browse Endometrial Neoplasms studies →197 of the 714 studies in Endometrial Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Crescent Biopharma, Inc. · Sites in United States
Ages 18+
Sutro Biopharma, Inc. · Sites in United States
Ages 18+
Pfizer · Sites in United States, Australia, China and 2 more countries
Ages 18+ · Women only
City of Hope Medical Center · Sites in United States
Ages 18+ · Women only
UNC Lineberger Comprehensive Cancer Center · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 357 Endometrial Neoplasms studies recruiting now, 267 (75%) set no upper age limit and 54 (15%) stop at 75 or younger; 26 take children under 18; 23 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
714 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 276 · Phase 2 264 · Phase 3 40 · Phase 4 3
First in 1987; this study’s year is marked. 42 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 48 is below the median of 71 across 1,027 interventional studies indexed under Endometrial Neoplasms.
Median enrollment 60 across the 590 interventional studies, 148 across the 100 observational. Of the 383 that completed or were terminated, 132 (34%) have results posted.
This tab as a report to print or save as PDF → With an account.
274 of 714 have an industry lead sponsor. The 10 most frequent:
Compugen Ltd is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Compugen Ltd has 2 studies filed under Endometrial Neoplasms — fewer than ten, so there is no comparison to draw.
100 of the studies in Endometrial Neoplasms with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04634877Phase 3Merck Sharp & Dohme LLCStudy of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053) | 2026-11-20 |
| NCT03785288Phase 3Kara Romano, MDVaginal Cuff Brachytherapy Fractionation Study | 2027-01-30 |
| NCT05173987Phase 3Merck Sharp & Dohme LLCStudy of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15) | 2027-05-27 |
| NCT07044336Phase 3AstraZenecaPuxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01) | 2027-10-15 |
| NCT05256225Phase 3National Cancer Institute (NCI)Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma | 2027-10-31 |
Add all 100 to your calendar (.ics) → With an account.
Among the 714 studies in Endometrial Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Key Inclusion Criteria:
During cohort expansion: All subjects must have as defined by v1.1.
Expansion Cohorts:
Key Exclusion Criteria:
Key Exclusion Criteria For Dose Expansion Cohorts:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: COM701 in combination with BMS-986207 and nivolumab.
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.
Drug: COM701 in combination with BMS-986207 and nivolumab.
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.
Drug: COM701 in combination with BMS-986207 and nivolumab.
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.
Drug: COM701 in combination with BMS-986207 and nivolumab.
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.
Drug: COM701 in combination with BMS-986207 and nivolumab.
Study treatment with the 3 drug combination (COM701 in combination with BMS-986207 and nivolumab).
This study also gives Nivolumab. No intervention listed here names it: that was found by reading the record.
The proportion of subjects with adverse events on the study.
The proportion of subjects with any adverse event (AE) per CTCAE v5.0.
Time frame: 2 years.
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.
Time frame: Within the DLT window (1st 28 days) of the 1st cycle during dose escalation.
The recommended dose for expansion (RDFE) of the combination.
The dose of COM701 in combination with BMS-986207 and nivolumab for the expansion cohort.
Time frame: 2 years.
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.
Time frame: 2 years.
The objective response rate of subjects enrolled in cohorts 1-4.
Objective response rate per RECIST v1.1.
Time frame: 3 years.
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2020 to primary completion in May 2024, 44 months.
Of 80 phase 1/2 interventional studies under Endometrial Neoplasms, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 54 and three quarters within 106. This study's 44 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Compugen Ltd