NCT04225390CompletedPhase 2
Preconditioning of Tumor, Tumor Microenvironment and the Immune System to Immunotherapy
A Phase 2, Single Arm Study on Dacarbazine (DTIC) Followed by Immunotherapy Re-challenge in Unresectable or Metastatic Melanoma With Primary Resistance to PD-1/PD-L1 or PD-1 + CTLA-4 Blockade
Source: ClinicalTrials.gov · Last updated 10 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (actual)
- First submitted
- 3 Jan 2020
- Start date
- 13 Jan 2020
- Primary completion date
- 15 Jan 2026
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Diseases
- Melanoma
- NCT number
- NCT04225390
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 38
- From 13 Jan 2020 to the primary completion date, 15 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous chemotherapy in metastatic disease
- Previous response to checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA-4 blockade) in metastatic disease
Other illness
- Autoimmune disease requiring more than 10 mg prednisolone daily or other immunosuppressive drugs
Other
- Uvea melanoma, mucosal melanoma
- BRAF V600 mutation
- Active brain metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.