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

NCT04225390 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-02-10

No results posted yet for this study

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.

Conditions

  • Immunotherapy

Interventions

DRUG

Dacarbazine (DTIC)

Dacarbazine powder for IV solution

Sponsors & Collaborators

  • University Hospital Regensburg

    collaborator OTHER

  • Wuerzburg University Hospital

    collaborator OTHER

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-13
Primary Completion
2026-01-15
Completion
2026-01-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04225390 on ClinicalTrials.gov