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RecruitingLast updated: 15 May 2024

HARMONY ADJUVANT: This study is comparing the effectiveness of different immunotherapy treatments at preventing or delaying melanoma from coming back after it has been removed with surgeryA Phase 3 Trial of Fianlimab (Anti-LAG-3) and Cemiplimab Versus Pembrolizumab in the Adjuvant Setting in Patients With Completely Resected High-risk Melanoma

Clinical summary

Summary

This study is recruiting people with stage IIC, III or IV melanoma that has been completely surgically removed. Eligible participants will be randomly allocated to one of three treatment arms.

In Arm A (Experimental), participants will be administered one combination dose of fianlimab high dose and cemiplimab. 

In Arm B (Experimental), participants will be administered one combination dose of fianlimab low dose and cemiplimab.

In Arm C (Active Comparator), participants will be administered one dose of pembrolizumab co-infused with saline/dectrose placebo. 

All treatments will be administered by intravenous (IV) infusion once every 3 weeks. 

Conditions

This trial is treating patients with high-risk melanoma that has been removed with surgery

Cancer

Skin Cancers Skin

Age

People12+

Phase

III

Trial Acronym

HARMONY ADJUVANT

More information

Trial Identifiers

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Trial sponsor

Regeneron Pharmaceuticals

Scientific Title

A Phase 3 Trial of Fianlimab (Anti-LAG-3) and Cemiplimab Versus Pembrolizumab in the Adjuvant Setting in Patients With Completely Resected High-risk Melanoma

Eligibility

Inclusion

  1. All patients must be either stage IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition and have histologically confirmed melanoma that is completely surgically resected in order to be eligible as defined by the protocol
  2. Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery
  3. All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization, as described in the protocol

Exclusion

  1. Uveal melanoma
  2. Any evidence of residual disease after surgery by imaging, pathology, or cytology.
  3. Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required systemic treatment with immunosuppressive agents
  4. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol
  5. Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol
  6. Adolescent patients (≥12 to <18 years old) with body weight <40 kg

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

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

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