NCT05912244
Active, not recruiting
Phase 2
A Phase II Study of IO102/IO103 and Nivolumab-relatlimab Fixed Dose Combination in Untreated, Unresectable Stage III/IV Melanoma
Memorial Sloan Kettering Cancer Center9 sites in 1 country43 target enrollmentStarted: June 9, 2023Last updated:
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 43
- Locations
- 9
- Primary Endpoint
- Overall Response Rate (ORR)
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years at the time of informed consent
- •Patient must be able to provide informed consent.
- •Patient must have a histologically confirmed diagnosis of locally advanced unresectable stage III or metastatic stage IV melanoma not amenable to local therapy.
- •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.
- •Patients must have at least one extraskeletal, extracranial measurable melanoma lesion as defined by RECIST v1.
- •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.
- •Patients must have Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Adequate laboratory function at screening, defined as:
- •Hemoglobin ≥ 9.0 g/dL
- •WBC ≥ 2000/uL
Exclusion Criteria
- •Uveal melanoma
- •Untreated central nervous system (CNS) metastases or any leptomeningeal involvement. Asymptomatic brain metastases that have been treated with external radiotherapy are permitted.
- •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.
- •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.
- •Treatment with any live/attenuated vaccine within 30 days of first study treatment. Inactivated and mRNA vaccines are permitted.
- •6\. History of motor neuropathy considered to be of autoimmune origin to be of autoimmune origin (e.g., Guillain-Barre syndrome, myasthenia gravis)
- •Other active, concurrent malignancy that requires ongoing systemic treatment or interferes with radiographic assessment of melanoma response as determined by the investigator
- •History of severe allergic reactions to any unknown allergens or any components of the study drugs.
- •9\. Uncontrolled (i.e., unstable) concomitant medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety or compliance with the study procedures. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- •Active hepatitis B virus (HBV) with a viral load \>100 IU/mL
Arms & Interventions
IO102/IO103, Nivolumab, and Relatlimab
Experimental
All patients will be treated with nivolumab-relatlimab FDC on Day 1 of every 28-day cycle for up to two years. Patients will be treated with IO102/IO103 on Days 1 and 15 of the first two 28-day cycles, then on Day 1 of subsequent cycles for up to two total years of treatment.
Intervention: IO102/IO103 (Drug)
IO102/IO103, Nivolumab, and Relatlimab
Experimental
All patients will be treated with nivolumab-relatlimab FDC on Day 1 of every 28-day cycle for up to two years. Patients will be treated with IO102/IO103 on Days 1 and 15 of the first two 28-day cycles, then on Day 1 of subsequent cycles for up to two total years of treatment.
Intervention: Nivolumab-Relatlimab (Drug)
Outcomes
Primary Outcomes
Overall Response Rate (ORR)
Time Frame: 3 years
will be reported as the proportion of patients who experience a complete (CR) or partial response (PR) to treatment by RECIST v1.1
Secondary Outcomes
- Incidence of adverse events(up to 100 days after the last dose)
- Progression-free survival (PFS)(3 years)
Investigators
Study Sites (9)
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