What side effects are associated with this type of intervention?

Common treatments for uterine cancer, particularly those involving VEGF inhibitors like Cabozantinib and immunotherapeutic drugs like Dostarlimab, are associated with several side effects. VEGF inhibitors can cause hypertension, diarrhea, fatigue, and hand-foot syndrome. Immunotherapeutic drugs may lead to immune-related adverse events such as colitis, hepatitis, endocrinopathies, and skin reactions. Patients undergoing these treatments should be closely monitored for these potential side effects.

What prior FDA approvals exist?

FDA-approved treatments for uterine cancer that are similar to the combination of Cabozantinib and Dostarlimab include Bevacizumab, a VEGF inhibitor, and Pembrolizumab, an immunotherapeutic drug. Bevacizumab has been used in combination with chemotherapy for advanced or recurrent endometrial cancer, showing some efficacy in stabilizing the disease. Pembrolizumab, an anti-PD-1 therapy, has been approved for use in patients with advanced endometrial cancer that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). These treatments highlight the potential benefits of targeting VEGF pathways and utilizing immunotherapy in managing uterine cancer.

What other types of research exist?

Promising novel alternatives for uterine cancer treatment in 2024 include: 1) Bevacizumab (another VEGF inhibitor) combined with chemotherapy, which has shown efficacy in various gynecologic cancers. 2) mTOR inhibitors like Temsirolimus and Everolimus, which have demonstrated potential in combination with other agents. 3) PARP inhibitors for patients with specific genetic mutations, which are being increasingly used in maintenance therapy. 4) Pembrolizumab, a PD-1 inhibitor, which has shown promise in various cancers and may be effective in combination with other treatments.

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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

No Placebo-Only Group

Summary

This trial tests a combination of two drugs, Cabozantinib and Dostarlimab, for patients with recurrent gynecologic carcinosarcoma. Cabozantinib works by blocking proteins that help tumors grow blood vessels, while Dostarlimab helps the immune system attack cancer cells. The goal is to improve treatment effectiveness by using both drugs together.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-Free Survival at 6 months

Side effects data

From 2021 Phase 2 trial • 53 Patients • NCT03308942

57%

Nausea

52%

Decreased appetite

48%

Constipation

48%

Anaemia

43%

Fatigue

38%

Dyspnoea

24%

Platelet count decreased

24%

Stomatitis

24%

Vomiting

24%

Oedema peripheral

19%

Insomnia

19%

Arthralgia

19%

Pruritus

19%

Blood alkaline phosphatase increased

14%

Cough

14%

Chills

14%

Pain

14%

Neutrophil count decreased

14%

Back pain

14%

Muscular weakness

14%

Diarrhoea

14%

Upper respiratory tract infection

14%

Dysgeusia

14%

Weight decreased

14%

Pneumonia

10%

Wheezing

10%

Urinary tract infection

10%

Aspartate aminotransferase increased

10%

Blood creatinine increased

10%

Alanine aminotransferase increased

10%

Lymphocyte count decreased

10%

Anxiety

10%

Depression

10%

Rash maculo-papular

10%

Erythema

10%

Atrial fibrillation

10%

Overdose

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

Pyrexia

Asthenia

Dysphonia

Nasal congestion

Intestinal obstruction

Pneumonitis

Toxicity to various agents

Lactic acidosis

Hyponatraemia

Hypomagnesaemia

Dizziness

Headache

Lethargy

Pain in extremity

Tachycardia

Hypotension

Cardiac arrest

Candida infection

Hyperhidrosis

Sinus tachycardia

Fall

Contusion

Abdominal pain

Gastrooesophageal reflux disease

Pulmonary embolism

Sepsis

Diverticulitis

Pericardial effusion

Angina pectoris

Cancer pain

Neuroendocrine carcinoma of the skin

Haematochezia

Malaise

Amylase increased

Peripheral sensory neuropathy

Syncope

Hyperglycaemia

Hepatic enzyme increased

Lipase increased

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Stage 1 (Cohort 2): Niraparib + Pembrolizumab

Stage 2 (Cohort 1A): Niraparib + TSR-042 (Dostarlimab)

Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab)

Stage 1 (Cohort 1): Niraparib + Pembrolizumab

Stage 1 (Cohort 3): Niraparib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for uterine cancer include VEGF inhibitors and immunotherapeutic drugs. VEGF inhibitors, such as Cabozantinib, block the vascular endothelial growth factor, which is essential for tumor blood vessel formation, thereby inhibiting tumor growth and spread. Immunotherapeutic drugs like Dostarlimab target immune checkpoints (e.g., PD-1), boosting the immune system's ability to recognize and destroy cancer cells. This combination can enhance the overall treatment efficacy by simultaneously starving the tumor of nutrients and enhancing immune-mediated tumor cell destruction, offering a promising approach for patients with recurrent or advanced uterine cancer.

PI3K/AKT/mTOR inhibitors for advanced or recurrent endometrial cancer.Developments in the systemic treatment of endometrial cancer.