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VEGF Inhibitor
Cabozantinib + Dostarlimab for Gynecologic Cancers
Phase 1 & 2
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will test whether combining a VEGF inhibitor with immunotherapy will be more effective in treating gynecologic cancers than either treatment alone.
Who is the study for?
This trial is for adults with recurrent gynecologic carcinosarcoma who've had at least one chemotherapy treatment. They must have a certain level of hemoglobin, white blood cells, and platelets, no serious illnesses or recent surgeries, and can't be pregnant or breastfeeding. Participants need to agree to use contraception and not have used certain drugs recently.Check my eligibility
What is being tested?
The study tests Cabozantinib (a drug that inhibits blood vessel growth in tumors) combined with Dostarlimab (an immunotherapy drug) on patients with recurring gynecological cancers. It aims to see if this combination improves the body's immune response against cancer cells.See study design
What are the potential side effects?
Potential side effects may include high blood pressure due to VEGF inhibition, fatigue from the immune system being activated by Dostarlimab, as well as possible liver issues or diarrhea. The exact side effects will vary between individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival at 6 months
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cabo + DostarlimabExperimental Treatment1 Intervention
Cabozantinib 40 mg by mouth every day + Dostarlimab 500 mg intravenous every 3 weeks followed by maintenance therapy: Cabozantinib 40 mg by mouth every day + Dostarlimab 1000 mg intravenous every 6 weeks
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,625 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot swallow pills.I have not had major surgery recently.I do not have any severe ongoing illnesses.My blood tests show my organs and bone marrow are working well.My cancer is a type called carcinosarcoma.I have a serious illness that makes it risky for me to try new drugs.I have been treated with cabozantinib before.I haven't been diagnosed with another cancer type in the last 2 years.I currently have an active infection.I have not taken any small molecule kinase inhibitors recently.I am not currently undergoing chemotherapy or radiation.I am not pregnant and can become pregnant.I have a history of lung conditions, autoimmune diseases, problems absorbing food, need for dialysis, or have had an organ or stem cell transplant.I am 18 years old or older.I am not breastfeeding while on this treatment.I am currently taking blood thinners as prescribed.I have recovered from previous treatment side effects, or they are minor and stable.I haven't had radiation for bone metastasis in the last 2 weeks or any other radiation in the last 4 weeks.My brain metastases are treated and stable for at least 4 weeks.I have not received a live vaccine in the last 30 days.I can take care of myself and perform daily activities.I have undergone at least one chemotherapy treatment for my cancer.I haven't had any cancer treatment recently.
Research Study Groups:
This trial has the following groups:- Group 1: Cabo + Dostarlimab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for participants in this research project?
"The information present on clinicaltrials.gov reveals that the subject trial is no longer accepting participants, with its initial post dating from January 1st 2023 and the most recent update being November 9th 2022. Despite this, there are 2,772 other studies actively recruiting patients at present."
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