CompletedPhase 2

Preconditioning of Tumor, Tumor Microenvironment and the Immune System to Immunotherapy

Germany38 participantsStarted 2020-01-13

Plain-language summary

PROMIT is a single arm phase 2 trial evaluating the clinical activity of immune checkpoint blockade (ICB) after administration of dacarbazine (DTIC) in patients with unresectable or metastatic, BRAF wildtype melanoma with primary resistance to anti-programmed-cell-death-1 (PD-1/PD-L1) or PD-1 plus anti-cytotoxic-T-lymphocyte antigen 4 (CTLA-4) blockade therapy. If the activity is clinically meaningful, DTIC could become a new therapeutic option to break primary resistance to immunotherapy.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Histologically confirmed metastatic melanoma
✓. Progression after checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA-4 blockade)
✓. Accessible tumor metastases
✓. ECOG 0 or 1
✓. Adequate organ function

Exclusion criteria

✕. Uvea melanoma, mucosal melanoma
✕. Previous chemotherapy in metastatic disease
✕. Previous response to checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA-4 blockade) in metastatic disease
✕. BRAF V600 mutation
✕. Active brain metastases
✕. Autoimmune disease requiring more than 10 mg prednisolone daily or other immunosuppressive drugs

What they're measuring

Rate of participents with CR, PR, SD or PD

Timeframe: week 14

Trial details

NCT IDNCT04225390

SponsorUniversity of Erlangen-Nürnberg Medical School

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-15

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