40 Participants Needed

Ubamatamab + Cemiplimab for Tumors

PM
Overseen ByPavlos Msaouel, MD,PHD,PHD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Cemiplimab, used in treating certain cancers, has shown acceptable safety in clinical trials, with low rates of treatment discontinuation and death. However, specific safety data for the combination with Ubamatamab is not provided in the available research.12356

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 | MD Anderson Cancer Center

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

I am eligible whether or not I've had my kidney removed due to cancer.
Consent to MD Anderson companion laboratory protocol 2014-0938
I have at least one tumor that can be measured.
See 7 more

Exclusion Criteria

Participants with known or suspected autoimmune disease
I have received an organ transplant from another person.
I have not had major surgery or significant injury in the last 4 weeks.
See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

6 weeks
Weekly visits 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.

Variable, depending on disease progression
Weekly visits for ubamatamab, then combination therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Cemiplimab
  • Ubamatamab
Trial Overview The study is testing the effectiveness of a drug named Ubamatamab alone or when used together with another drug called Cemiplimab. The goal is to see if these treatments can control the disease in patients.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Stage IExperimental Treatment1 Intervention
Stage 1 of study treatment involves being given ubamatamab by itself by vein. The first dose will be given over about 4 hours. Depending on how participants respond, later doses may be given over shorter periods of time (possibly down to 30 minutes per infusion). Participants dose of ubamatamab will be increased from a starting dose on Day 1 to a full dose on Day 15. Participants will receive ubamatamab 1 time every week for the first 4 weeks, then every 3 weeks after that, unless the disease gets worse or intolerable side effects occur. • If the disease gets worse after completing 6 weeks of treatment, participants will move to Stage 2 and receive combination therapy.
Group II: Stage 2Experimental Treatment2 Interventions
Participants in Stage 2 will begin receiving ubamatamab and cemiplimab. * If participants are enrolled directly into Stage 2, but did not have therapy with ubamatamab alone, participants will receive ubamatamab 1 time each week for 4 weeks, before beginning combination therapy. * If participants have already completed Stage 1 and are moving on to Stage 2, participants will begin with combination therapy. During Stage 2, ubamatamab is given by vein over 30 minutes to 4 hours, as described above. Cemiplimab is given by vein over 30 minutes.

Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:

🇪🇺
Approved in European Union as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)
  • Non-small cell lung cancer (NSCLC)
🇺🇸
Approved in United States as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)
  • Basal cell carcinoma (BCC)
  • Non-small cell lung cancer (NSCLC)
🇨🇦
Approved in Canada as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)
  • Non-small cell lung cancer (NSCLC)
🇧🇷
Approved in Brazil as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Regeneron Pharmaceuticals

Industry Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Findings from Research

Cemiplimab-rwlc is a newly approved PD-1/L1 inhibitor for first-line treatment of metastatic non-small cell lung cancer (NSCLC) without EGFR or ALK mutations, either alone or with chemotherapy.
This review highlights the differences in patient populations studied for cemiplimab compared to other treatments, emphasizing its role in expanding options for NSCLC patients.
Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations.Ahn, J., Nagasaka, M.[2023]
Atezolizumab, cemiplimab, and pembrolizumab are established as standard first-line immunotherapy options for patients with advanced non-small cell lung cancer (NSCLC) who have high PD-L1 expression (≥50%).
The consensus among 25 Spanish lung cancer experts indicates that these therapies can be tailored to specific patient subgroups, enhancing treatment decision-making based on differences observed in pivotal clinical trials.
PD-1/PD-L1 Inhibitors as Monotherapy in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer Patients with High PD-L1 Expression: An Expert Position Statement.Isla, D., Sánchez, A., Casal, J., et al.[2023]
Cemiplimab is a PD-1 monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, which is crucial for enhancing the immune response against cancer cells.
In September 2018, cemiplimab received FDA approval for treating patients with metastatic or locally advanced cutaneous squamous cell carcinoma who cannot undergo curative surgery or radiation, marking a significant advancement in cancer treatment options.
Cemiplimab: First Global Approval.Markham, A., Duggan, S.[2023]

References

Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations. [2023]
PD-1/PD-L1 Inhibitors as Monotherapy in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer Patients with High PD-L1 Expression: An Expert Position Statement. [2023]
Cemiplimab: First Global Approval. [2023]
Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. [2022]
Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. [2019]
Cemiplimab in advanced cutaneous squamous cell carcinoma. [2022]
A Comparison of the Antitumor Efficacy of Novel Multi-Specific Tribodies with Combinations of Approved Immunomodulatory Antibodies. [2023]
A Mucin 16 bispecific T cell-engaging antibody for the treatment of ovarian cancer. [2020]
Taking up Cancer Immunotherapy Challenges: Bispecific Antibodies, the Path Forward? [2020]
Alternative molecular formats and therapeutic applications for bispecific antibodies. [2021]
Bispecific antibodies for cancer therapy: A review. [2019]
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