Comparing Opdualag with Nivolumab for cutaneous melanoma

Exclusion

• −History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to anti-PD-1 or anti-LAG-3 or any of their excipients.
• −Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
• −Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive Hepatitis B virus (HBV) surface antigen \[HBsAg\] result), or hepatitis C (HCV). Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Subjects with well-controlled Human Immunodeficiency Virus (HIV) are allowed.
• −Diagnosis of uveal melanoma.
• −Any prior systemic anticancer therapy for melanoma. Any concurrent anticancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is allowed.
• −Evidence of metastatic disease at surgical and radiological staging.
• −History of allogeneic organ transplantation.
• −History of active primary immunodeficiency.
• −Active autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], immune related diverticulitis \[prior diverticulitis in the context of diverticulosis is allowed provided is not active\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\].
• −The following are exceptions to this criterion:
• −Participants with vitiligo or alopecia
• −Participants with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
• −Any chronic skin condition that does not require systemic therapy. Participants without active disease in the last 1 year may be included but only after consultation with the Principal InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
• −Participants with celiac disease controlled by diet alone
• −Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, clinically relevant coronary artery disease or history of myocardial infarction in the last 4 months or high risk of uncontrolled arrhythmia, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) or compromise the ability of the participant to give written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
• −History of another primary malignancy except for:
• −Malignancy treated with curative intent and with no known active disease ≥ 3 years before the first dose of study treatment and of low potential risk for recurrence.
• −Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
• −Adequately treated carcinoma in situ without evidence of disease.
• −Participants with a history of prostate cancer (tumor/node/metastasis stage) of Stage ≤ T2cN0M0 without biochemical recurrence or progression and who in the opinion of the investigator are not deemed to require active intervention
• −Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 500 msecs calculated from three ECGs.
• −Prior nivolumab or relatlimab therapy.
• −Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention. The following are exceptions to this criterion (see Section 4.7.1.1):
• −Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection)
• −Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
• −Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Participants should not receive live vaccine whilst receiving study intervention and up to 30 days after the last dose of study intervention. Should the participants be deemed candidates for the Monkey pox vaccine, the case will need to be discussed with the coordinating Principal Investigator.
• −Participation in another clinical study with an investigational product administered in the last 28 days prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → or concurrent enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in another clinical study, unless the study is an observationalObservational studyA study that watches what happens without assigning any treatment.Read more → (non-interventionalInterventional studyA study where participants are given something to see what happens.Read more →) clinical study or during the follow-up periodFollow-upContinued check-ins after the treatment part is finished.Read more → of an interventional study.
• −Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
• −Subjects who are unable to willingly provide consent or are unable to comply with the protocolProtocolThe detailed plan a study must follow.Read more → procedures.
• −For women only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.