NCT03354962

Induction of Immune-mediated aBscOpal Effect thrOugh STEreotactic Radiation Therapy in Metastatic Melanoma Patients Treated by PD-1 + CTLA-4 Inhibitors (BOOSTER MELANOMA)

Terminated Phase 1, PHASE2 Last updated 4 December 2020

What this trial tests

Phase 1, PHASE2 trial testing Nivolumab + Ipilimumab in Melanoma in 6 participants. Terminated before completion.

Timeline

15 October 2018

Primary endpoint
20 February 2020

27 October 2020

Quick facts

Lead sponsor	Institut Claudius Regaud
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	15 October 2018
Primary completion	20 February 2020
Estimated completion	27 October 2020
Sites	6 locations across France

Drugs / interventions tested

• Nivolumab + Ipilimumab
• Combined treatment schema

Conditions studied

• Melanoma — all drugs for Melanoma →

Sponsor

Institut Claudius Regaud — full company profile →

Who can join

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

Sponsor's own description

This study is a phase I/II, multicenter, open-label study starting with a phase I part followed by a Phase II part.

The phase I part of the study aims at evaluating the safety and efficacy (in terms of abscopal effect at week 6) of the treatment combination schema of Stereotactic Body Radiation Therapy (SBRT) and PD-1 plus CTLA-4 inhibitors in patients with metastatic melanoma. Patients will be assigned in one of 3 cohorts depending the metastatic site. 18 patients will be enrolled in each cohort.

Once the recommended optimal radiotherapy dose has been declared for the 3 cohorts, patients will be enrolled in the phase II part of the study in order to evaluate the activity (progression-free survival at 6 months) of SBRT given in combination with immune checkpoints inhibitors in patients with metastatic melanoma.

66 patients will be included in the phase II.

Publications & conference data

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

1. Radiotherapy and immune response: the systemic effects of a local treatment.
   Carvalho HA, Villar RC. · · 2018 · cited 159× · PMID 30540123 · DOI 10.6061/clinics/2018/e557s
2. Management of metastatic cutaneous melanoma: updates in clinical practice.
   Schvartsman G, Taranto P, Glitza IC, Agarwala SS, et al · · 2019 · cited 29× · PMID 31205512 · DOI 10.1177/1758835919851663
3. Immune Checkpoint-Mediated Interactions Between Cancer and Immune Cells in Prostate Adenocarcinoma and Melanoma.
   Elia AR, Caputo S, Bellone M. · · 2018 · cited 26× · PMID 30108594 · DOI 10.3389/fimmu.2018.01786
4. Checkpoint Inhibition: Will Combination with Radiotherapy and Nanoparticle-Mediated Delivery Improve Efficacy?
   Lamichhane P, Amin NP, Agarwal M, Lamichhane N. · · 2018 · cited 15× · PMID 30360504 · DOI 10.3390/medicines5040114
5. Radiobiology of stereotactic ablative radiotherapy (SABR): perspectives of clinical oncologists.
   Li S, Shen L. · · 2020 · cited 11× · PMID 32742453 · DOI 10.7150/jca.44408
6. Complete and Durable Response After Radiation Therapy to Primary Tumor Site of a Patient With Metastatic Anorectal Mucosal Melanoma With Oligoprogression on Nivolumab.
   Wallington DG, Rashid AS, Buchwald ZS, Sudmeier LJ, et al · · 2020 · cited 5× · PMID 32529147 · DOI 10.1016/j.adro.2020.02.006
7. The role of immunotherapy in the management of patients with renal cell carcinoma and brain metastases.
   Fallah J, Ahluwalia MS. · · 2019 · cited 1× · PMID 32016032 · DOI 10.21037/atm.2019.10.31
8. Radiotherapy as salvage therapy and an adjunct to immunotherapy: exploring local and abscopal mechanisms to overcome immunotherapy resistance: a narrative review.
   Yang Y, Liu T, Mi S, Liu X, et al · · 2025 · PMID 40114936 · DOI 10.21037/tlcr-2025-57