194 Participants Needed

Cemiplimab + ISA101b for HPV-Related Throat Cancer

Recruiting at 66 trial locations
SV
Overseen BySonja Visscher
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive medications like steroids, you may need to stop them 14 days before starting the study drug.

What data supports the effectiveness of the drug Cemiplimab + ISA101b for HPV-related throat cancer?

Research on similar drugs like pembrolizumab, an immune checkpoint inhibitor, shows it has antitumor activity in head and neck cancers, including those related to HPV. This suggests that similar treatments, like Cemiplimab, may also be effective in treating HPV-related throat cancer.12345

Is the combination of Cemiplimab and ISA101b generally safe for humans?

Cemiplimab, also known as Libtayo, has been studied for various cancers and is generally considered to have an acceptable safety profile. Common side effects are manageable, and no new safety concerns were observed in combination therapies. However, specific safety data for the combination with ISA101b is not provided in the available research.678910

How is the drug cemiplimab unique for treating HPV-related throat cancer?

Cemiplimab is unique because it is an immunotherapy drug that works by blocking the PD-1 receptor, which helps the immune system attack cancer cells more effectively. This approach is different from traditional chemotherapy, which directly targets and kills cancer cells, and it represents a novel option for treating cancers that are sensitive to immune system modulation.4681011

What is the purpose of this trial?

This trial is testing a combination of a cancer vaccine and a drug to help the immune system fight HPV16 positive oropharyngeal cancer. The vaccine teaches the immune system to attack cancer cells, and the drug keeps the immune system active. The vaccine targets cancers related to HPV, including cervical, oropharyngeal, and anal cancers.

Research Team

BS

Bonnie Glisson, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults diagnosed with HPV16 positive recurrent or metastatic OPC (a type of throat cancer), whose tumors express a protein called PD-L1 and are suitable for first-line therapy with PD-1 blocking antibodies, or have progressed after chemotherapy. Participants must be in good physical condition (ECOG 0-1) and not have used certain immunosuppressive drugs recently. Women must test negative for pregnancy.

Inclusion Criteria

I have signed the consent form approved by the ethics committee.
My cancer is HPV16 positive, expresses PD-L1, and has either not been treated or progressed after chemotherapy.
Be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
See 10 more

Exclusion Criteria

You have had an allergic reaction to cemiplimab or any of its ingredients.
I haven't taken high doses of steroids or other immune-weakening medicines in the last 14 days.
I haven't had cancer, except for certain skin, cervix, prostate, breast, or bladder cancers in the last 3 years.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cemiplimab plus placebo or cemiplimab plus ISA101b every 3 weeks for up to 24 months

24 months
Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

Treatment Details

Interventions

  • Cemiplimab
  • ISA101b
  • Placebo
Trial Overview This phase 2 trial is testing the effectiveness of Cemiplimab combined with ISA101b versus Cemiplimab with a placebo in treating HPV16-positive OPC. Patients will be randomly assigned to one of these two groups without knowing which treatment they receive.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active ISA101b and cemiplimab.Experimental Treatment2 Interventions
ISA101b 3 times plus cemiplimab every 3 weeks for up to 24 months
Group II: Placebo and cemiplimabPlacebo Group2 Interventions
Placebo 3 times plus cemiplimab every 3 weeks for up to 24 months

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?

ISA Pharmaceuticals

Lead Sponsor

Trials
5
Recruited
400+

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

The Phase III trial KEYNOTE-412 is designed to evaluate the efficacy and safety of pembrolizumab, an immune checkpoint inhibitor, when used alongside chemoradiation therapy (CRT) in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).
Previous Phase Ib studies have indicated that combining pembrolizumab with CRT is safe and feasible, supporting its potential use in this larger trial to improve treatment outcomes for patients with locally advanced HNSCC.
Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412.Machiels, JP., Tao, Y., Burtness, B., et al.[2021]
Pembrolizumab, an immune checkpoint inhibitor, has shown significantly improved overall survival in patients with relapsed and/or metastatic head and neck squamous cell carcinoma compared to the standard EXTREME regimen, indicating a promising shift in treatment options.
This review highlights the importance of understanding the mechanisms of immune checkpoint inhibitors, including their interaction with the immune system and the challenges posed by tumor heterogeneity and PD-L1 expression, which are crucial for optimizing patient selection for treatment.
Potential of Pembrolizumab in Metastatic or Recurrent Head and Neck Cancer: Evidence to Date.McCusker, MG., Orkoulas-Razis, D., Mehra, R.[2020]
Pembrolizumab, an immune checkpoint inhibitor, has been approved by the FDA for treating platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC), offering a new option with potentially improved efficacy compared to traditional chemotherapy and EGFR inhibitors.
This review discusses the pharmacology and tolerability of pembrolizumab, emphasizing its mechanism of action by blocking the PD-1 receptor, which may enhance the immune response against HNSCC tumors.
Pembrolizumab and its use in the treatment of recurrent or metastatic head and neck cancer.Sheth, S., Weiss, J.[2019]

References

Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412. [2021]
Pembrolizumab for Platinum- and Cetuximab-Refractory Head and Neck Cancer: Results From a Single-Arm, Phase II Study. [2023]
Potential of Pembrolizumab in Metastatic or Recurrent Head and Neck Cancer: Evidence to Date. [2020]
Pembrolizumab and its use in the treatment of recurrent or metastatic head and neck cancer. [2019]
Carboplatin-pemetrexed in treatment of patients with recurrent/metastatic cancers of the head and neck; superior outcomes in oropharyngeal primaries. [2020]
Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. [2019]
Phase I Trial of Cemiplimab, Radiotherapy, Cyclophosphamide, and Granulocyte Macrophage Colony-Stimulating Factor in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. [2021]
PD-1 blockade in recurrent or metastatic cervical cancer: Data from cemiplimab phase I expansion cohorts and characterization of PD-L1 expression in cervical cancer. [2021]
Safety and preliminary activity of pembrolizumab-carboplatin-paclitaxel in heavily pretreated and/or fragile patients with PDL1-positive recurrent/metastatic head and neck cancer. [2023]
Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Neoadjuvant and Adjuvant Pembrolizumab in Resectable Locally Advanced, Human Papillomavirus-Unrelated Head and Neck Cancer: A Multicenter, Phase II Trial. [2021]
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