NCT04225390 (PROMIT) is a Phase 2 clinical trial of Dacarbazine (DTIC) in Immunotherapy, sponsored by University of Erlangen-Nürnberg Medical School.

Who is sponsoring NCT04225390?

NCT04225390 is sponsored by University of Erlangen-Nürnberg Medical School.

What drugs are being tested in NCT04225390?

Interventions in NCT04225390: Dacarbazine (DTIC).

What condition does NCT04225390 study?

NCT04225390 studies Immunotherapy.

Is NCT04225390 still recruiting?

NCT04225390 is currently completed. Last updated 10 February 2026.

Last reviewed 2026-02-10 · How we verify

NCT04225390: PROMIT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 10 February 2026

What this trial tests

Phase 2 trial testing Dacarbazine (DTIC) in Immunotherapy in 38 participants. Completed in 15 January 2026.

Timeline

13 January 2020

Primary endpoint
15 January 2026

15 January 2026

Quick facts

Lead sponsor	University of Erlangen-Nürnberg Medical School
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	38
Start date	13 January 2020
Primary completion	15 January 2026
Estimated completion	15 January 2026
Sites	1 location across Germany

Drugs / interventions tested

Dacarbazine (DTIC) — full drug profile →

Conditions studied

Immunotherapy — all drugs for Immunotherapy →

Sponsor

University of Erlangen-Nürnberg Medical School

Who can join

18 and older, any sex, with Immunotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Tumor microenvironment enriches the stemness features: the architectural event of therapy resistance and metastasis.
Nallasamy P, Nimmakayala RK, Parte S, Are AC, et al · · 2022 · cited 163× · PMID 36550571 · DOI 10.1186/s12943-022-01682-x
Current Melanoma Treatments: Where Do We Stand?
Moreira A, Heinzerling L, Bhardwaj N, Friedlander P. · · 2021 · cited 36× · PMID 33435389 · DOI 10.3390/cancers13020221
Targeting Genome Stability in Melanoma-A New Approach to an Old Field.
Osrodek M, Wozniak M. · · 2021 · cited 7× · PMID 33800547 · DOI 10.3390/ijms22073485
Tumor Niche Influences the Activity and Delivery of Anticancer Drugs: Pharmacology Meets Chemistry.
Ravera M, Gabano E, Tonello S, Colangelo D. · · 2025 · cited 1× · PMID 40732334 · DOI 10.3390/ph18071047
Breaking primary checkpoint inhibitor resistance with intermittent alkylating chemotherapy in patients with metastatic melanoma: results of a multicentre phase II trial.
Haferkamp S, Schilling B, Berking C, Drexler K, et al · · 2026 · PMID 40905153 · DOI 10.1093/bjd/ljaf350

Verify or expand the search:

Other trials of Dacarbazine (DTIC)

Trials testing the same drug.

NCT04200040 — A Clinical Study to Evaluate the Safety and Efficacy of OrienX010 in Unresectable Malignant Melanoma Patients · Phase 2 · unknown
NCT01227889 — A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced · Phase 3 · completed

Other recruiting trials for Immunotherapy

Currently open trials in the same condition.

NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
NCT07475403 — Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer · Phase 2 · recruiting
NCT07458529 — Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer · Phase 2 · recruiting
NCT07436845 — Impact of Emotional Status on Prognosis of Patients With BCLC Stage B/C Hepatocellular Carcinoma Undergoing Hepatic Arte · recruiting
NCT06671613 — Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer · NA · recruiting

Other University of Erlangen-Nürnberg Medical School trials

Trials by the same sponsor.

NCT06969820 — Establishment and Evaluation of Standardized Clinical, Biological and Imaging Parameters to Assess the Response of LDRT · not yet recruiting
NCT07406191 — WB-EMS Effects on Cardiometabolic Risk Factors · NA · recruiting
NCT07352540 — Single vs Triple Hyaluronic Acid in Knee Osteoarthritis · Phase 2, PHASE3 · not yet recruiting
NCT07313878 — Evaluation of Acute and Chronic Nephrotoxicity in Acute Lymphatic Leukemia Patients Using Ultrasound Localization Micros · NA · recruiting
NCT07121985 — Multispectral Optoacoustic Imaging for the Detection of Inflammation and Damage of Peripheral Nerves in Guillain-Barré S · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04225390 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Erlangen-Nürnberg Medical School
Last refreshed: 10 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04225390.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing