Preconditioning of Tumor, Tumor Microenvironment and the Immune System to Immunotherapy (PROMIT)

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 + CTLA4 Blockade Preconditioning of Tumor, Tumor Microenvironment and the Immune System to Immunotherapy (PROMIT) - PROMIT

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003556-23-DE

Enrollment

Registered

2018-04-04

Start date

2019-10-15

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma MedDRA version: 20.0 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 100000004864

Interventions

Trade Name: Detimedac Pharmaceutical Form: Powder and solvent for solution for infusion Trade Name: Opdivo Product Name: Opdivo Pharmaceutical Form: Concentrate for solution for infusion Trade Name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Key inclusion criteria: 1. Histologically confirmed metastatic melanoma 2. Progression after checkpoint inhibitor therapy (anti-PD-1/PD-L1 containing regimens) 3. Accessible tumor metastases 4. ECOG 0 or 1 5. Adequate organ function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16

Exclusion criteria

Exclusion criteria: Key exclusion criteria: 1. Uvea melanoma, mucosal melanoma 2. Previous chemotherapy in metastatic disease 3. Previous response to checkpoint inhibitor therapy (regimen containing PD-1 or PD-L1 inhibitors) in metastatic disease 4. BRAF V600 mutation 5. Active brain metastases or autoimmune disease requiring more than 10 mg prednisolone daily or other immunosuppressive drugs

Design outcomes

Primary

Measure	Time frame
Main Objective: Dacarbazine (DTIC) chemotherapy sensitizes metastatic melanoma towards immunotherapy First primary objective: Improvement of the overall response rate (ORR) Second primary objective: Increase of the overall survival (OS) ;Secondary Objective: Secondary objectives: 1) Collect biological samples (tissue/blood/stool) to assess immunological changes 2) Quality of life ;Primary end point(s): Primary Endpoint 1) Overall response rate (ORR), defined as the number of subjects showing a complete response (CR) or partial response (PR) (RECIST 1.1) at week 14 2) Overall Survival (OS), defined as the time between study inclusion and date of death (any cause). For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive. OS will be followed continuously while subjects are on the study drug and every 12 weeks via phone contact after subjects discontinue the treatment phase.;Timepoint(s) of evaluation of this end point: ORR: week 14; OS: 2 years or until death	—

Measure

Time frame

Main Objective: Dacarbazine (DTIC) chemotherapy sensitizes metastatic melanoma towards immunotherapy First primary objective: Improvement of the overall response rate (ORR) Second primary objective: Increase of the overall survival (OS) ;Secondary Objective: Secondary objectives: 1) Collect biological samples (tissue/blood/stool) to assess immunological changes 2) Quality of life ;Primary end point(s): Primary Endpoint 1) Overall response rate (ORR), defined as the number of subjects showing a complete response (CR) or partial response (PR) (RECIST 1.1) at week 14 2) Overall Survival (OS), defined as the time between study inclusion and date of death (any cause). For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive. OS will be followed continuously while subjects are on the study drug and every 12 weeks via phone contact after subjects discontinue the treatment phase.;Timepoint(s) of evaluation of this end point: ORR: week 14; OS: 2 years or until death

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Secondary

Measure	Time frame
Secondary end point(s): Secondary Endpoints 1) Collect biological samples (tissue/blood/stool) to assess immunological changes 2) Assess quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).;Timepoint(s) of evaluation of this end point: 1) Biological samples: timepoint see Table 3.1-1 in clinical trial protocol 2) Quality of life: Baseline, week 14	—

Measure

Time frame

Secondary end point(s): Secondary Endpoints 1) Collect biological samples (tissue/blood/stool) to assess immunological changes 2) Assess quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).;Timepoint(s) of evaluation of this end point: 1) Biological samples: timepoint see Table 3.1-1 in clinical trial protocol 2) Quality of life: Baseline, week 14

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Countries

Germany

Contacts

Public ContactHautklinik Erlangen

University Hospital FAU Erlangen / Department of dermatology

lucie.heinzerling@uk-erlangen.de+ 4991318545804

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026