A Biomarker Study in Advanced Mucosal or Acral Lentiginous Melanoma Receiving Nivolumab in Combination With Ipilimumab

NCT02978443 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2016-0420CA209-763
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 5

Brief Summary

Participants with advanced or metastatic mucosal melanoma (cohort A) and acral lentiginous melanoma (cohort B) eligible for treatment with nivolumab in combination with ipilimumab followed by nivolumab therapy will submit tissue blocks from tumors of malignant melanoma for histopathology review and immunohistochemistry analysis at Georgetown University-Lombardi Comprehensive Cancer Center. Pretreatment blood will be drawn and stored in the Melanoma Research Foundation Breakthrough Consortium Virtual Repository at each participating institution. At the end of participation, samples will be sent to Georgetown University-Lombardi Comprehensive Cancer Center for processing and storage. An optional pretreatment biopsy of an accessible tumor lesion will be performed in a subset of enrolled patients. Patients will receive nivolumab in combination with ipilimumab according to the standard FDA approved treatment regimen.

Conditions

Acral Lentiginous Melanoma; Mucosal Melanoma

Keywords

Melanoma; Mucosal; Acral Lentiginous; Ipilimumab; Nivolumab; Anti-tumor; Potential Predictors; Opdivo; Yervoy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) With Mucosal Melanoma (MCM)

  ORR, defined as complete response \[CR\] + partial response \[PR\] per RECIST 1.1 criteria and to compare this response rate to the response rate of patients with "good" molecular predictive features

  24 months

Secondary Outcomes (3)

• Objective Response Rate With Acral Lentiginous Melanoma (ALM)

  24 months

• Progression-free Survival (PFS)

  33 months

• Overall Survival (OS)

  44 months

Study Arms (1)

Nivolumab-Ipilimumab Combination Therapy

EXPERIMENTAL

All patients will receive nivolumab administered IV over 60 minutes at 1 mg/kg combined with ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks until progression, intolerable toxicity, or a maximum of 48 weeks, whichever comes first (Maintenance). Patients exhibiting complete response (CR) should continue nivolumab monotherapy at least 12 weeks beyond documentation of CR, if possible.

Drug: Nivolumab; Drug: Ipilimumab

Interventions

Nivolumab DRUG

nivolumab administered IV over 60 minutes at 1 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks

Also known as: BMS-936558, Opdivo

Nivolumab-Ipilimumab Combination Therapy

Ipilimumab DRUG

ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction)

Also known as: BMS-734016, Yervoy

Nivolumab-Ipilimumab Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed MCM or ALM that is metastatic or unresectable.
• Patients must be eligible to receive nivolumab in combination with ipilimumab treatment per institutional guidelines.
• Patients must have a tissue block (or 20 unstained slides) available with adequate tumor to perform multiplex immunohistochemistry and nucleic acids analyses ( i.e. whole exome sequencing) Patients with only a previous fine-needle aspirate are ineligible for enrollment.
• Patients must be willing to donate a small amount of whole blood prior to treatment and during treatment for laboratory analysis.
• Patients must give informed consent prior to initiation of therapy.
• Patients must be ambulatory with good performance status (ECOG 0 or 1)

You may not qualify if:

• Patients who do not have available tissue for immunohistochemistry and nucleic acids analyses.
• Patients who have received prior immunotherapy for unresectable or metastatic disease.
• Patients with untreated brain metastases, leptomeningeal disease, or seizure disorders are ineligible. Patients with a history of brain metastases must have completed treatment (i.e. surgery or radiation) 1 month prior to enrollment and have no evidence of disease or edema on brain CT or head MRI.
• Patients with inadequate tissue for analysis.

Sponsors & Collaborators

• Georgetown University: lead
• Melanoma Research Foundation Breakthrough Consortium: collaborator
• Bristol-Myers Squibb: collaborator
• University of Colorado, Denver: collaborator
• University of California, San Francisco: collaborator
• Vanderbilt University: collaborator
• Columbia University: collaborator
• University of Pittsburgh: collaborator
• Yale University: collaborator
• M.D. Anderson Cancer Center: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• Northwestern University: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (5)

Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Washington Cancer Institute at MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

John Theurer Cacner Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Suthee Rapisuwon
• Organization: Georgetown University

Suthee.Rapisuwon@medstar.net

202-877-6583

Study Officials

• Suthee Rapisuwon, MD

  Lombardi Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: December 1, 2016
• Study Start: July 26, 2017
• Primary Completion: July 28, 2020
• Study Completion: August 2, 2022
• Last Updated: April 4, 2024
• Results First Posted: April 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)