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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
Side effects data
From 2021 Phase 2 trial • 53 Patients • NCT0330894257%
Nausea
52%
Decreased appetite
48%
Constipation
48%
Anaemia
43%
Fatigue
38%
Dyspnoea
24%
Stomatitis
24%
Platelet count decreased
24%
Vomiting
24%
Oedema peripheral
19%
Pruritus
19%
Arthralgia
19%
Insomnia
19%
Blood alkaline phosphatase increased
14%
Muscular weakness
14%
Neutrophil count decreased
14%
Pain
14%
Back pain
14%
Cough
14%
Diarrhoea
14%
Upper respiratory tract infection
14%
Dysgeusia
14%
Weight decreased
14%
Chills
14%
Pneumonia
10%
Depression
10%
Overdose
10%
Aspartate aminotransferase increased
10%
Blood creatinine increased
10%
Atrial fibrillation
10%
Lymphocyte count decreased
10%
Alanine aminotransferase increased
10%
Anxiety
10%
Rash maculo-papular
10%
Urinary tract infection
10%
Erythema
10%
Wheezing
10%
Haemorrhoidal haemorrhage
10%
Pleural effusion
10%
Oropharyngeal pain
10%
Productive cough
10%
Non-cardiac chest pain
10%
Chest pain
10%
Dehydration
10%
Hypokalaemia
10%
Hypophosphataemia
10%
Pain of skin
10%
Haemorrhoids
10%
Gait disturbance
10%
Neuropathy peripheral
10%
Hypothyroidism
10%
Vision blurred
10%
Proctalgia
5%
Lactic acidosis
5%
Nasal congestion
5%
Tachycardia
5%
Toxicity to various agents
5%
Asthenia
5%
Pneumonitis
5%
Pyrexia
5%
Lethargy
5%
Hypomagnesaemia
5%
Headache
5%
Hyponatraemia
5%
Pain in extremity
5%
Hypotension
5%
Dizziness
5%
Dysphonia
5%
Cardiac arrest
5%
Candida infection
5%
Hyperhidrosis
5%
Sinus tachycardia
5%
Fall
5%
Contusion
5%
Abdominal pain
5%
Gastrooesophageal reflux disease
5%
Pulmonary embolism
5%
Sepsis
5%
Diverticulitis
5%
Pericardial effusion
5%
Intestinal obstruction
5%
Angina pectoris
5%
Cancer pain
5%
Neuroendocrine carcinoma of the skin
5%
Haematochezia
5%
Malaise
5%
Amylase increased
5%
Peripheral sensory neuropathy
5%
Syncope
5%
Hyperglycaemia
5%
Hepatic enzyme increased
5%
Lipase increased
5%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stage 1 (Cohort 2): Niraparib + Pembrolizumab
Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab)
Stage 2 (Cohort 1A): Niraparib + TSR-042 (Dostarlimab)
Stage 1 (Cohort 1): Niraparib + Pembrolizumab
Stage 1 (Cohort 3): Niraparib
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
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,593 Previous Clinical Trials
2,282,597 Total Patients Enrolled
Media Library
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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