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Patient pathway

NRAS melanoma after PD-1 / PD-L1 failure

A pathway for the hard next-line conversation after checkpoint therapy stops working.

Conversation bucket

Checkpoint history

Write down the exact PD-1 / PD-L1 drug, dates, response, progression date, and whether combination immunotherapy was used.

Conversation bucket

NRAS / MEK pathway

MEK inhibitor discussions are drug- and country-specific. Tunlametinib / HL-085 is tracked as China-specific, not globally assumed.

Conversation bucket

Cell therapy / TIL

Lifileucel is a U.S. FDA accelerated-approval record in a specific post-PD-1 melanoma context and requires specialized-center discussion.

Conversation bucket

Lookalike trials

Some NRAS trials combine targeted and immune drugs but are not tunlametinib. Keep each drug name separate.

Keep these separate

Similar-sounding options do not carry the same evidence.

TermCategoryStatusCaution
Tunlametinib / HL-085MEK inhibitorChina-specific conditional approval contextDo not assume global availability.
Tunlametinib + nivolumabMEK inhibitor + PD-1 inhibitorLived-context / unresolved exact public trial leadDo not present as proven melanoma trial evidence.
Belvarafenib + cobimetinib + nivolumabRAF/MEK/PD-1 trial strategyClinicalTrials.gov NRAS trial leadDo not merge this evidence into tunlametinib claims.
Lifileucel / TILCell therapyU.S. FDA accelerated-approval contextRequires specialized-center and timing discussion.

What this situation means

  • Prior PD-1/PD-L1 failure is a key fact for trials, MEK-pathway research, TIL questions, and local-control planning.

What not to assume

  • Do not assume a MEK inhibitor is globally available or that MEK plus PD-1 is standard.

Information to gather

  • Prior immunotherapy names and dates
  • scan timeline
  • NRAS report
  • current disease sites
  • trial search constraints

Bring to the surgeon

  • Is any site useful for biopsy or local control?

Bring to the oncologist

  • Should we search NRAS trials before starting another line?
  • Is TIL therapy or a specialty center consult relevant?
  • What evidence supports any MEK inhibitor being discussed?

Bring to the trial team

  • Does prior PD-1 failure match the trial's entry rules?
  • Would starting a MEK inhibitor affect whether a later trial fits?

Related database records

Related treatment pages

clinical-trial

Clinical trials in melanoma

Trial listings can show studies that mention a cancer, mutation, drug, or treatment history, but a listing match does not mean a study fits.

clinical-trial

Clinical trials in melanoma

Trial listings can show studies that mention a cancer, mutation, drug, or treatment history, but a listing match does not mean a study fits.

immunotherapy

Lifileucel / TIL therapy

TIL therapy is different from ordinary checkpoint immunotherapy. A tumor sample is used to grow a patient's own immune cells outside the body, then the cells are given back through a specialized treatment program.

Related trial leads

A trial record is a lead only. The trial team must confirm whether it fits.

Phase 1/2 · completed

NCT03973151

Primary early clinical trial record for HL-085/tunlametinib in NRAS-mutant advanced melanoma.

This record is not the exact tunlametinib plus nivolumab combination remembered by the user.

Phase 3 · recruiting

NCT06008106

Phase III comparator trial after prior immunotherapy; useful for duration-of-response and trial-timing questions.

A trial listing match does not mean the trial fits. The trial team must confirm.

Phase 1/2 · unknown

NCT04375527

Supports the broader research concept of MEK inhibitor plus PD-1 inhibitor in melanoma, but not tunlametinib specifically.

Do not use this as evidence for tunlametinib plus nivolumab.

Phase 1 · unknown

NCT04835805

A sourced NRAS melanoma trial lead after anti-PD-1/PD-L1 therapy that may explain a remembered MEK/RAF plus PD-1 trial concept.

This is belvarafenib/cobimetinib/nivolumab, not tunlametinib/nivolumab.

Phase 1/2 · completed

NCT03979651

NRAS melanoma research lead involving MEK inhibition and autophagy inhibition.

Trial record does not make this a routine treatment option.

Related cohort threads

Sources with the medical details

  1. Tunlametinib Capsules approved with conditions for marketing by China NMPA. Accessed 2026-05-20.
  2. First-in-human phase I dose-escalation and dose-expansion trial of HL-085 in advanced melanoma harboring NRAS mutations. Accessed 2026-05-20.
  3. NCT03973151: Study of HL-085 in NRAS Mutant Advanced Melanoma. Accessed 2026-05-20.
  4. NCT06008106: Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma. Accessed 2026-05-20.
  5. NCT04375527: Binimetinib and nivolumab in BRAF V600 wild-type melanoma. Accessed 2026-05-20.
  6. NCT04835805: Belvarafenib alone or with cobimetinib or cobimetinib plus nivolumab in NRAS-mutant advanced melanoma. Accessed 2026-05-20.
  7. NCT03979651: Trametinib plus hydroxychloroquine in metastatic or unresectable NRAS melanoma. Accessed 2026-05-20.
  8. FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma. Accessed 2026-05-20.
  9. Drugs Approved for Melanoma. Accessed 2026-05-20.