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Can chemotherapy reboot immunotherapy in resistant melanoma?

NCT ID NCT04225390

Disease control Sponsor: University of Erlangen-Nürnberg Medical School Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested whether giving the chemotherapy drug dacarbazine (DTIC) before re-trying immunotherapy could help patients with advanced melanoma whose cancer had stopped responding to immunotherapy. The study enrolled 38 adults with metastatic melanoma that had progressed after PD-1/PD-L1 or PD-1 plus CTLA-4 blockade. The goal was to see if DTIC could break resistance and allow immunotherapy to work again.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dacarbazine (DTIC)
What this could lead to
If successful, this approach could offer a new way to overcome resistance to immunotherapy in advanced melanoma patients.
What could go wrong
This is a small, single-arm phase 2 trial with only 38 participants, so results may not apply broadly. The treatment may not improve outcomes and could cause side effects from chemotherapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

38 people

The number who actually took part.

Started

Jan 2020

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically confirmed metastatic melanoma 2. Progression after checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA-4 blockade) 3. Accessible tumor metastases 4. ECOG 0 or 1 5. Adequate organ function Exclusion Criteria: 1. Uvea melanoma, mucosal melanoma 2. Previous chemotherapy in metastatic disease 3. Previous response to checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA-4 blockade) in metastatic disease 4. BRAF V600 mutation 5. Active brain metastases 6. Autoimmune disease requiring more than 10 mg prednisolone daily or other immunosuppressive drugs

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Conditions

The condition(s) this trial relates to.

metastatic melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immunotherapy

Contacts and locations

Locations

  • University Hospital

    Erlangen, Bavaria, 91054, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.