New hope for advanced melanoma: immunotherapy combo tested in india
NCT ID NCT07459543
First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times
Summary
This study tests a combination of two immunotherapy drugs, nivolumab and relatlimab, in people with advanced melanoma that hasn't been treated before. The goal is to see if the combination is safe and helps shrink tumors. About 30 adults and teens (ages 12 and up) in India will take part. This is an early safety-focused study, not a cure, but it may offer a new treatment option.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria \- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for minors (ages 12-17) ONLY. Note: Participants with ECOG PS 2 are allowed if the performance status of 2 is attributable to disease burden (and not to significant comorbidity), and if the investigator and Medical Monitor agree the patient may benefit from treatment. * Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) staging system (8th edition). * Participants must have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. * Participants must have completed prior radiotherapy at least 2 weeks prior to study treatment administration. * Individuals of Childbearing Potential (IOCBP) must not be pregnant or breastfeeding. Exclusion Criteria * Participants must not have active brain metastases or leptomeningeal metastases. * Participants must not have uveal melanoma. * Participants must not have an active, known, or suspected autoimmune disease. Note: Participants may enroll with the following conditions: i) type 1 diabetes mellitus; ii) hypothyroidism only requiring hormone replacement; iii) skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment; iv) conditions not expected to recur in the absence of an external trigger are permitted to enroll. \- Participants must not have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Note: Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. * Participants must not have a history of myocarditis. * Other protocol-defined Inclusion/Exclusion criteria apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Local Institution - 0001
New Delhi, 110085, India
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Local Institution - 0002
Chennai, 600006, India
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Local Institution - 0003
Bhubaneswar, Odisha, 751007, India
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Local Institution - 0004
New Delhi, 110029, India
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Local Institution - 0005
Nagpur, 440001, India
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Local Institution - 0006
Mumbai, 400 012, India
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Local Institution - 0008
Pune, Maharashtra, 411017, India
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Local Institution - 0009
Navi Mumbai, Maharashtra, 400614, India
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Local Institution - 0010
Mumbai, Maharashtra, 400052, India
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Local Institution - 0011
Bhubaneswar, 751019, India
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Local Institution - 0012
Nashik, Dādra and Nagar Haveli and Damān and Diu, 422001, India
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A quest to find biomarkers that match melanoma patients with the right immunotherapy
- Can a triple immunotherapy attack beat advanced melanoma?
- Can a flash of radiation tame melanoma skin lesions?
- Can ultrasound predict cancer drug response earlier?
- Can targeted radiation boost the power of immunotherapy against melanoma?
- Can a One-Two punch of immune boosters revive cancer treatment?