ACTIVE_NOT_RECRUITING

A Study of IO102/IO103, Nivolumab, and Relatlimab in People With Melanoma

Conditions

Melanoma IO102/IO103 Nivolumab Relatlimab Unresectable Stage III/IV 23-098

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The researchers are doing this study to find out whether the study vaccines, IO102/IO103, given in combination with the standard-of-care drug combination, nivolumab and relatlimab, is a safe and effective treatment for people with untreated, unresectable melanoma.

Official Title

A Phase II Study of IO102/IO103 and Nivolumab-relatlimab Fixed Dose Combination in Untreated, Unresectable Stage III/IV Melanoma

Quick Facts

Study Start:2023-06-09

Study Completion:2027-06-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05912244

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥ 18 years at the time of informed consent 2. Patient must be able to provide informed consent. 3. Patient must have a histologically confirmed diagnosis of locally advanced unresectable stage III or metastatic stage IV melanoma not amenable to local therapy. 4. Patient must have not received any prior systemic therapy directed against unresectable stage III or IV melanoma. Prior neoadjuvant and adjuvant ICIs and BRAF/MEK inhibitors are permitted as long as the last dose was \> 6 months prior to recurrence. 5. Patients must have at least one extraskeletal, extracranial measurable melanoma lesion as defined by RECIST v1.1. Note: A formal RECIST read by a study radiologist is not needed at the time of enrollment. Measurable disease can be assessed by the treating investigator. 6. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. 7. Adequate laboratory function at screening, defined as: 1. Hemoglobin ≥ 9.0 g/dL 2. WBC ≥ 2000/uL 3. Platelet count ≥ 100 × 10\^9 /L 4. Serum direct bilirubin ≤ 1.5 × upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN. (Total bilirubin \< 3 mg/dL for subjects with Gilbert's disease) 5. Calculated creatinine clearance (CrCl) ≥15 mL/min based on the Cockcroft-Gault equation 8. Patients of childbearing potential\* who are sexually activ partner must use two methods of effective contraception from screening, and must agree to continue using such precautions for 23 weeks after the final dose of investigational product: cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 9. Male patients who are sexually active with partners of childbearing potential must use highly effective methods of contraception throughout the study and for at least four months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period.	1. Uveal melanoma 2. Untreated central nervous system (CNS) metastases or any leptomeningeal involvement. Asymptomatic brain metastases that have been treated with external radiotherapy are permitted. 3. Any immunotherapy treatment for unresectable stage III/IV melanoma or any other prior unresectable malignancy. Prior neoadjuvant and adjuvant ICIs and BRAF/MEK inhibitors are permitted as long as the last dose was \> 6 months prior to recurrence. 4. Systemic steroid therapy higher than physiologic dose steroid replacement (\>10 mg/day of prednisone or equivalent), given within 14 days of starting treatment, or other immunosuppressive medications within 14 days of the start of treatment. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. 5. Treatment with any live/attenuated vaccine within 30 days of first study treatment. Inactivated and mRNA vaccines are permitted.

Inclusion Criteria

Exclusion Criteria

1. Age ≥ 18 years at the time of informed consent
2. Patient must be able to provide informed consent.
3. Patient must have a histologically confirmed diagnosis of locally advanced unresectable stage III or metastatic stage IV melanoma not amenable to local therapy.
4. Patient must have not received any prior systemic therapy directed against unresectable stage III or IV melanoma. Prior neoadjuvant and adjuvant ICIs and BRAF/MEK inhibitors are permitted as long as the last dose was \> 6 months prior to recurrence.
5. Patients must have at least one extraskeletal, extracranial measurable melanoma lesion as defined by RECIST v1.1. Note: A formal RECIST read by a study radiologist is not needed at the time of enrollment. Measurable disease can be assessed by the treating investigator.
6. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
7. Adequate laboratory function at screening, defined as:
1. Hemoglobin ≥ 9.0 g/dL
2. WBC ≥ 2000/uL
3. Platelet count ≥ 100 × 10\^9 /L
4. Serum direct bilirubin ≤ 1.5 × upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN. (Total bilirubin \< 3 mg/dL for subjects with Gilbert's disease)
5. Calculated creatinine clearance (CrCl) ≥15 mL/min based on the Cockcroft-Gault equation
8. Patients of childbearing potential\* who are sexually activ partner must use two methods of effective contraception from screening, and must agree to continue using such precautions for 23 weeks after the final dose of investigational product: cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control.
9. Male patients who are sexually active with partners of childbearing potential must use highly effective methods of contraception throughout the study and for at least four months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period.

1. Uveal melanoma
2. Untreated central nervous system (CNS) metastases or any leptomeningeal involvement. Asymptomatic brain metastases that have been treated with external radiotherapy are permitted.
3. Any immunotherapy treatment for unresectable stage III/IV melanoma or any other prior unresectable malignancy. Prior neoadjuvant and adjuvant ICIs and BRAF/MEK inhibitors are permitted as long as the last dose was \> 6 months prior to recurrence.
4. Systemic steroid therapy higher than physiologic dose steroid replacement (\>10 mg/day of prednisone or equivalent), given within 14 days of starting treatment, or other immunosuppressive medications within 14 days of the start of treatment. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. 5. Treatment with any live/attenuated vaccine within 30 days of first study treatment. Inactivated and mRNA vaccines are permitted.

Contacts and Locations

Principal Investigator

James Smithy, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Hartford Healthcare Alliance (Data Collection Only)

Hartford, Connecticut, 06102

United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

United States

Lehigh Valley Health Network (Data Collection Only)

Allentown, Pennsylvania, 18103

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

James Smithy, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-09

Study Completion Date2027-06-09

Study Record Updates

Study Start Date2023-06-09

Study Completion Date2027-06-09

Terms related to this study

Keywords Provided by Researchers

IO102/IO103
Nivolumab
Relatlimab
Unresectable
Stage III/IV
23-098

Additional Relevant MeSH Terms

Melanoma