Dostarlimab and Cobolimab in Advanced Cervical Cancer
- Conditions
- Cervical CancerAdvanced Cervical CarcinomaMetastatic Cervical CancerMetastatic Cervical CarcinomaRecurrent Cervical Carcinoma
- Interventions
- Registration Number
- NCT06238635
- Lead Sponsor
- Meghan Shea
- Brief Summary
This research is being done to determine how effective dostarlimab in combination with cobolimab is in metastatic or recurrent cervical cancer.
- Detailed Description
This is a non-randomized, open-label, two-arm phase 2 trial of dostarlimab and cobolimab for participants with metastatic or recurrent cervical cancer who have or have not been treated with immunotherapy previously.
The names of the study drugs involved in this study are:
* Cobolimab (a type of monoclonal antibody)
* Dostarllimab (a type of monoclonal antibody)
The U.S. Food and Drug Administration (FDA) has not approved cobolimab as a treatment for cervical cancer.
The FDA has not approved dostarlimab for cervical cancer but it has been approved for other uses.
The study procedures including, screening for eligibility, treatment visits, blood tests, x-rays, Computerized Tomograph (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission Tomograph (PET) scans.
Participants will be followed for up to 7 years.
It is expected that about 66 people will take part in this research study.
GlaxoSmithKline is funding this research study by providing funding and the study drugs.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 66
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A: Immunotherapy Naive Dostarlimab 10 Participants will complete study procedures as follows: * Baseline visit. * Imaging tests at baseline visit, at week 9, and then every 12 weeks. * Cycle 1 through End of Treatment (up to 2 years of treatment): • Day 1 of 21 Day cycle: Dostarlimab 1x daily and Cobolimab 1x daily. * End of Treatment visit with blood tests and imaging tests. * Follow Up Period: Every 3 months for 2 years and then every 6 months for an additional 5 years. Includes imaging tests. If \>= 2 participants with objective responses, then 19 additional participants will be enrolled. Cohort B: Immunotherapy Exposed Dostarlimab 14 Participants will complete study procedures as follows: * Baseline visit. * Imaging tests at baseline visit, at week 9, and then every 12 weeks. * Cycle 1 through End of Treatment (up to 2 years of treatment): • Day of 21 Day cycle: Predetermined dose of Dostarlimab 1x daily. Predetermined dose of Cobolimab 1x daily. * End of Treatment visit with blood tests and imaging tests. * Follow Up Period: Every 3 months for 2 years and then every 6 months for an additional 5 years. Includes imaging tests. If \>= 2 participants with objective responses, then 23 additional participants will be enrolled. Cohort A: Immunotherapy Naive Cobolimab 10 Participants will complete study procedures as follows: * Baseline visit. * Imaging tests at baseline visit, at week 9, and then every 12 weeks. * Cycle 1 through End of Treatment (up to 2 years of treatment): • Day 1 of 21 Day cycle: Dostarlimab 1x daily and Cobolimab 1x daily. * End of Treatment visit with blood tests and imaging tests. * Follow Up Period: Every 3 months for 2 years and then every 6 months for an additional 5 years. Includes imaging tests. If \>= 2 participants with objective responses, then 19 additional participants will be enrolled. Cohort B: Immunotherapy Exposed Cobolimab 14 Participants will complete study procedures as follows: * Baseline visit. * Imaging tests at baseline visit, at week 9, and then every 12 weeks. * Cycle 1 through End of Treatment (up to 2 years of treatment): • Day of 21 Day cycle: Predetermined dose of Dostarlimab 1x daily. Predetermined dose of Cobolimab 1x daily. * End of Treatment visit with blood tests and imaging tests. * Follow Up Period: Every 3 months for 2 years and then every 6 months for an additional 5 years. Includes imaging tests. If \>= 2 participants with objective responses, then 23 additional participants will be enrolled.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) Based on irRECIST Up to 2 years ORR based on irRECIST is defined as the proportion of participants who achieved partial response or complete response during study treatment based on immune-related RECIST criteria.
- Secondary Outcome Measures
Name Time Method Median Progression-Free Survival (PFS) Up to 3 years PFS is defined as the time from registration to the earlier of progression (PD) or death due to any cause based on Kaplan-Meier methodology. Participants alive without disease progression are censored at date of last disease evaluation.
Median Overall Survival (OS) Up to 3 years OS is defined as the time from registration to death due to any cause, or censored at date last known alive based on Kaplan-Meier methodology.
Immune-Related (PFS) Progression-Free Survival Up to 7 years PFS is defined as the time from registration to disease progression or censored at date of last contact.
Grade 3-5 Adverse Events Rate Up to 2 years Grade 3-5 AE rate is defined as the proportion of participants who experienced grade 3-5 adverse event based on the Common Toxicity Criteria for Adverse Events version 5.0 as reported on case report form.
Trial Locations
- Locations (2)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States