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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Jun 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people with melanoma, a type of skin cancer that has spread and cannot be surgically removed. The researchers want to see if two experimental vaccines, called IO102 and IO103, can work safely and effectively when given alongside standard treatments nivolumab and relatlimab. The goal is to find better options for patients who have not yet received treatment for their advanced melanoma.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of advanced melanoma that is not amenable to local treatment. They should not have previously received certain types of cancer therapies for this condition. Potential participants will undergo screening to ensure they are healthy enough to participate and must agree to use effective birth control methods during the study. If someone joins the trial, they can expect regular visits to the clinic for assessments and treatment, and they will be closely monitored for any side effects. This trial is currently recruiting participants, and being part of it could help advance treatment options for melanoma.

Gender

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Eligibility criteria

• Inclusion 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.
• • \*Patients of childbearing potential are defined as those who are assigned female at birth and not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).
• • 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.
• Exclusion Criteria:
• • 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.
• • 6. History of motor neuropathy considered to be of autoimmune origin to be of autoimmune origin (e.g., Guillain-Barre syndrome, myasthenia gravis) 7. Other active, concurrent malignancy that requires ongoing systemic treatment or interferes with radiographic assessment of melanoma response as determined by the investigator 8. 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. 10. Active hepatitis B virus (HBV) with a viral load \>100 IU/mL 11. Active hepatitis C virus (HCV) with a viral load \>100 IU/mL 12. Patients who are breastfeeding or who are pregnant as evidenced by a positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) performed within 14 days of the first dose of study drug.
• • 13. Prisoners or participants who are involuntarily incarcerated. (Note: Under certain specific circumstances where local regulations permit, a person who has been imprisoned may be permitted to continue as a participant.) 14. Participants who are compulsorily detained for treatment of either a psychiatric or physical illness (e.g., transmissible infection)