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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:
Participants will:
Trial CPG-01-201 is an adaptive-platform trial comprised of multiple sub-studies.
Sub-study 1 will be a parallel group, double-blind, randomized placebo-controlled trial in which participants will be randomized in a 1:2 ratio to either placebo (a look-alike substance that contains no drug) or COM701 treatment arms. This means that there is a 33% chance of being placed in the group getting placebo and a 67% chance of being placed in the group that will get the experimental COM701 antibody.
Subsequent sub-studies will evaluate COM701 in combination with other anti-cancer drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COM701 | Experimental |
| |
| Normal Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COM701 | Drug | COM701 will be administered via intravenous (IV) infusion once every 3 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia Cancer Center at Augusta University | Recruiting | Augusta | Georgia | 30912 | United States |
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Within 12 months of final database lock
To be decided
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This is an adaptive platform trial enabling the evaluation of COM701 initially as a single agent compared to placebo in relapsed PSOC. This will enable the evaluation of the effects of COM701 as a single agent followed by the potential to adjust the trial to evaluate combinations with COM701.
A data monitoring committee will review all safety and efficacy data on a regular basis and will make recommendations regarding study unblinding and timing to start additional sub-studies evaluating COM701 in combination with other anti-cancer drugs.
An interim analysis will be conducted when approximately 60 participants in sub-study 1 have been followed for approximately 9 months.
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| Normal Saline |
| Drug |
Saline will be administered via intravenous (IV) infusion once every 3 weeks |
|
| 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 | 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. |
| The University of Chicago Medical Center | Recruiting | Chicago | Illinois | 60637 | United States |
|
| Northwestern Memorial Hospital | Recruiting | Warrenville | Illinois | 60555 | United States |
|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| Corewell Health | Recruiting | Grand Rapids | Michigan | 49503 | United States |
|
| Memorial Sloan Kettering Cancer Center- Main Campus | Recruiting | New York | New York | 10065 | United States |
|
| University of Rochester Medical Center | Recruiting | Rochester | New York | 14642 | United States |
|
| Levine Cancer Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
|
| Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run | Recruiting | Hilliard | Ohio | 43026 | United States |
|
| OU Health Stephenson Cancer Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
|
| UPMC Magee- Womens Hospital | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
|
| Avera Cancer Institute | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
|
| West Cancer Center | Withdrawn | Germantown | Tennessee | 38138 | United States |
| UVA Comprehensive Cancer Center | Recruiting | Charlottesville | Virginia | 22903 | United States |
|
| Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz | Recruiting | Besançon | France | 25000 | France |
|
| Oncopole Claudius Regaud | Recruiting | Toulouse | France | 31059 | France |
|
| Centre Oscar Lambret | Recruiting | Lille | 59000 | France |
|
| Institut Paoli-Calmettes | Recruiting | Marseille | 13009 | France |
|
| Hospices Civils de Lyon- Centre Hospitalier Lyon Sud | Recruiting | Pierre-Bénite | 69310 | France |
|
| Centre Eugene Marquis | Recruiting | Rennes | 35042 | France |
|
| Institut de Cancerologie de l'Ouest- Site Rene Gauducheau | Recruiting | Saint-Herblain | 44805 | France |
|
| Gustave Roussy | Recruiting | Villejuif | 94800 | France |
|
| Assuta Medical Center | Recruiting | Ashdod | 7747629 | Israel |
|
| Rambam Health Care Campus | Recruiting | Haifa | 3109601 | Israel |
|
| The Edith Wolfson Medical Center | Recruiting | Holon | 5822012 | Israel |
|
| Shaare Zedek Medical Center | Recruiting | Jerusalem | 9103102 | Israel |
|
| Hadassah, University Hospital Ein Kerem | Recruiting | Jerusalem | 9112001 | Israel |
|
| The Chaim Sheba Medical Center | Recruiting | Ramat Gan | 5265601 | Israel |
|
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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