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RecruitingLast updated: 6 February 2024

KeyForm-010: This study is evaluating different regimens of immunotherapy and targeted therapy in people with either cutaneous squamous cell carcinoma or endometrial cancerA Multicenter, Randomized, Double-Blind, Phase 2, Basket Study of MK-4280A, a Coformulation of Favezelimab (MK-4280) With Pembrolizumab (MK-3475) in Selected Solid Tumors (KeyForm-010)

Clinical summary

Summary

This study has two cohorts, and each cohort has two arms. Within each Cohort participants will be randomised into arms to receive treatment. Treatment cycles are 21 days in length.

Cohort A is evaluating a conformulation of two immunotherapies (favezelimab/pembrolizumab), compared to pembrolizumab immunotherapy alone, in people with cutaenous squamous cell carcinoma (cSCC).

  • Participants in the favezelimab/pembrolizumab arm will receive coformulated favezelimab/pembrolizumab (800mg/200mg) via intravenous (IV) infusion every 3 weeks for 3 cycles in the neoadjuvant period, and 14 cycles of adjuvant therapy. 
  • Participants in the pembrolizumab monotherapy arm will receive pembrolizumab (200mg) via IV infusion every 3 weeks in the neoadjuvant period and 14 cycles of adjuvant therapy. 

In both arms, participants who do not complete all 3 adjuvant cycles should have additional cycles in the adjuvant period so the total number of study intervention administrations is 17 treatment cycles. 

Cohort B is evaluating a targeted therapy called lenvatinib in combination with coformulated favezelimab/pembrolizumab, compared to lenvatinib in combination with pembrolizumab, in people with proficient in mismatch repair (pMMR) endometrial cancer (EC).

  • Participants in the favezelimab/pembrolizumab + lenvatinib arm will receive coformulated favezelimab/pembrolizumab (800mg/200mg) via IV infusion every 3 weeks for up to 35 cycles PLUS lenvatinib (20mg) every day via oral capsule until disease progression, unacceptable toxicity, or discontinuation criteria are met..
  • Participants in the pembrolizumab + lenvatinib arm will receive pembrolizumab (200mg) via IV infusion every 3 weeks fo rup to 35 cycles PLUS lenvatinib (20mg) every day via oral capsule until disease progression, unacceptable toxicity, or discontinuation criteria are met.

Conditions

This trial is treating patients with cutaneous squamous cell carcinoma or endometrial cancer

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

II

Trial Acronym

KeyForm-010

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • NCT06036836
  • MK4280A-010; MK-4280A-010; 2023-505022-34; 4280A-010

Trial sponsor

Merck Sharp & Dohme LLC,NCT06036836

Scientific Title

A Multicenter, Randomized, Double-Blind, Phase 2, Basket Study of MK-4280A, a Coformulation of Favezelimab (MK-4280) With Pembrolizumab (MK-3475) in Selected Solid Tumors (KeyForm-010)

Eligibility

Inclusion

Cohort A only

  • Histologically confirmed diagnosis of resectable cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted)
  • Stage II to Stage IV disease without distant metastasis (M1). cSCC tumors arising in the head and neck will be staged according to American Joint Committee on Cancer (AJCC) Edition (Ed.) 8 and cSCC tumors arising in non-head and neck locations will be staged according to Union for International Cancer Control (UICC) Ed. 8
  • Is systemic treatment naïve
  • Archival tumor tissue sample, or newly obtained surgical resection, or biopsy sample of a tumor lesion not previously irradiated has been provided
  • Is an individual of any sex/gender, at least 18 years of age at the time of providing the informed consent

Cohort B only

  • Histologically confirmed diagnosis of endometrial cancer (EC) that is not deficient in mismatch repair (dMMR) proficient in mismatch repair (pMMR) as documented by a local test report
  • Documented evidence of stage IVB (per 2009 International Federation of Gynecology and Obstetrics (FIGO) staging), recurrent, or metastatic EC, and are not candidates for curative surgery or radiation
  • Has radiographic evidence of disease progression after 1 prior systemic, platinum-based chemotherapy regimen for EC in any setting
  • Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) by investigator (before first dose of study intervention)
  • Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent
  • Has adequately controlled blood pressure without antihypertensive medication

All Cohorts

  • Agrees to follow contraception guidelines if a participant of childbearing potential
  • Has a life expectancy >3 years per investigator assessment
  • Has adequate organ function
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • If positive for hepatitis B, has received antiviral therapy for ≥4 weeks and undetectable viral load prior to randomization
  • If positive for hepatitis C, has undetectable viral load at screening
  • If positive for human immunodeficiency virus (HIV), has well-controlled HIV on a stable highly active antiretroviral therapy

Exclusion

All Cohorts

  • Has known hypersensitivity to active substances or their excipients including previous clinically significant hypersensitivity reaction to treatment with other monoclonal antibody (mAb)
  • History of allogeneic tissue/solid organ transplant

Cohort A only

  • Received prior radiotherapy to the index lesion (in-field lesion)
  • Participants for whom the primary site of cSCC was anogenital area (penis, scrotum, vulva, perianal region) are not eligible

Cohort B

  • Has had major surgery within 3 weeks prior to first dose of study interventions
  • Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
  • Has urine protein ≥1 g/24 hours
  • Has a left ventricle ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multi-gated acquisition (MUGA) or echocardiogram (ECHO)
  • Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
  • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention

Inclusion

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • but it is not possible to perform surgery to remove it.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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