NCT01996202

A Pilot Study of Ipilumimab and Radiation in Poor Prognosis Melanoma

Completed Phase 1 Last updated 3 July 2019

What this trial tests

Phase 1 trial testing Ipilumimab in High Risk Melanoma in 24 participants. Completed in 1 September 2018.

Timeline

1 November 2013

Primary endpoint
1 September 2018

1 September 2018

Quick facts

Lead sponsor	Duke University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	1 November 2013
Primary completion	1 September 2018
Estimated completion	1 September 2018
Sites	1 location across United States

Drugs / interventions tested

• Ipilumimab — full drug profile →
• Radiation

Conditions studied

• High Risk Melanoma — all drugs for High Risk Melanoma →

Sponsor

Duke University

Who can join

Adults 18 to 100, any sex, with High Risk Melanoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of immune related adverse events associated with ipilimumab
  Time frame: 2 years
• Incidence of acute and late radiation toxicities
  Time frame: 2 years

Sponsor's own description

This is a pilot study assessing the safety of the combination of ipilimumab administered concurrently with radiotherapy for patients with locally advanced or unresectable melanoma and patients at high risk for recurrence after resection.

Publications & conference data

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

1. Abscopal effect of radiotherapy combined with immune checkpoint inhibitors.
   Liu Y, Dong Y, Kong L, Shi F, et al · · 2018 · cited 337× · PMID 30115069 · DOI 10.1186/s13045-018-0647-8
2. Current clinical trials testing the combination of immunotherapy with radiotherapy.
   Kang J, Demaria S, Formenti S. · · 2016 · cited 293× · PMID 27660705 · DOI 10.1186/s40425-016-0156-7
3. Combinations of immunotherapy and radiation in cancer therapy.
   Vatner RE, Cooper BT, Vanpouille-Box C, Demaria S, et al · · 2014 · cited 189× · PMID 25506582 · DOI 10.3389/fonc.2014.00325
4. In situ vaccination by radiotherapy to improve responses to anti-CTLA-4 treatment.
   Vanpouille-Box C, Pilones KA, Wennerberg E, Formenti SC, et al · · 2015 · cited 138× · PMID 26148880 · DOI 10.1016/j.vaccine.2015.05.105
5. Cytotoxic T lymphocyte antigen-4 and immune checkpoint blockade.
   Buchbinder E, Hodi FS. · · 2015 · cited 130× · PMID 26325034 · DOI 10.1172/jci80012
6. Trial Watch: Immunomodulatory monoclonal antibodies for oncological indications.
   Buqué A, Bloy N, Aranda F, Castoldi F, et al · · 2015 · cited 79× · PMID 26137403 · DOI 10.1080/2162402x.2015.1008814
7. Immunotherapy and radiotherapy in melanoma: a multidisciplinary comprehensive review.
   Tagliaferri L, Lancellotta V, Fionda B, Mangoni M, et al · · 2022 · cited 78× · PMID 33847208 · DOI 10.1080/21645515.2021.1903827
8. Ipilimumab (Anti-Ctla-4 Mab) in the treatment of metastatic melanoma: Effectiveness and toxicity management.
   Savoia P, Astrua C, Fava P. · · 2016 · cited 40× · PMID 26889818 · DOI 10.1080/21645515.2015.1129478