Ubamatamab + Cemiplimab for Tumors
Trial Summary
What is the purpose of this trial?
To find out if ubamatamab, given by itself or in combination with cemiplimab, can help to control the disease in participants with renal medullary carcinoma (RMC) and epithelioid sarcoma (ES).
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications. However, you cannot participate if you are currently receiving anticancer therapies or have received them within 2 weeks prior to the study. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug cemiplimab in treating tumors?
Cemiplimab has been shown to be effective in treating advanced non-small cell lung cancer and advanced cutaneous squamous cell carcinoma by enhancing the immune system's ability to fight tumors. It works by blocking a protein that usually helps cancer cells hide from the immune system, allowing the body to better attack the cancer.12345
Is the combination of Ubamatamab and Cemiplimab safe for humans?
What makes the drug Ubamatamab + Cemiplimab unique for treating tumors?
Ubamatamab + Cemiplimab is unique because it combines a bispecific antibody, Ubamatamab, which targets MUC16 on tumor cells and CD3 on T cells, with Cemiplimab, an anti-PD-1 antibody. This combination aims to enhance the immune system's ability to attack cancer cells by bridging them with T cells and overcoming resistance to traditional PD-1/PD-L1 therapies.7891011
Research Team
Pavlos Msaouel
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for individuals with specific tumors known as renal medullary carcinoma (RMC) and epithelioid sarcoma (ES). Participants must express a protein called MUC16 and lack another protein, SMARCB1, in their tumors.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Stage 1 Treatment
Participants receive ubamatamab by itself, starting with a dose on Day 1 and increasing to a full dose on Day 15. Ubamatamab is administered weekly for the first 4 weeks, then every 3 weeks.
Stage 2 Treatment
Participants receive combination therapy with ubamatamab and cemiplimab. Ubamatamab is given weekly for 4 weeks if not previously received, followed by combination therapy.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cemiplimab
- Ubamatamab
Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
- Basal cell carcinoma (BCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Regeneron Pharmaceuticals
Industry Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School