NCT01940809

Ipilimumab With or Without Dabrafenib, Trametinib, and/or Nivolumab in Treating Patients With Melanoma That Is Metastatic or Cannot Be Removed by Surgery

Terminated Phase 1 Last updated 10 March 2022

What this trial tests

Phase 1 trial testing Dabrafenib in BRAF V600E Mutation Present in 15 participants. Terminated before completion.

Timeline

28 August 2013

Primary endpoint
17 July 2020

4 March 2022

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	28 August 2013
Primary completion	17 July 2020
Estimated completion	4 March 2022
Sites	2 locations across United States

Drugs / interventions tested

• Dabrafenib (dabrafenib) — full drug profile →
• Ipilimumab — full drug profile →
• Laboratory Biomarker Analysis
• Nivolumab (nivolumab) — full drug profile →
• Trametinib (trametinib) — full drug profile →

Conditions studied

• BRAF V600E Mutation Present — all drugs for BRAF V600E Mutation Present →
• BRAF V600K Mutation Present — all drugs for BRAF V600K Mutation Present →
• Metastatic Melanoma — all drugs for Metastatic Melanoma →
• Stage III Cutaneous Melanoma AJCC v7 — all drugs for Stage III Cutaneous Melanoma AJCC v7 →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with BRAF V600E Mutation Present or BRAF V600K Mutation Present. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This randomized phase I trial studies the side effects and best way to give ipilimumab with or without dabrafenib, trametinib and/or nivolumab in treating patients with melanoma that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the ability of cancer cells to grow and spread. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether ipilimumab works better with or without dabrafenib, trametinib, and/or nivolumab in treating melanoma.

Publications & conference data

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

1. Current landscape and future of dual anti-CTLA4 and PD-1/PD-L1 blockade immunotherapy in cancer; lessons learned from clinical trials with melanoma and non-small cell lung cancer (NSCLC).
   Chae YK, Arya A, Iams W, Cruz MR, et al · · 2018 · cited 336× · PMID 29769148 · DOI 10.1186/s40425-018-0349-3
2. Signal pathways of melanoma and targeted therapy.
   Guo W, Wang H, Li C. · · 2021 · cited 251× · PMID 34924562 · DOI 10.1038/s41392-021-00827-6
3. AP-1 Transcription Factors as Regulators of Immune Responses in Cancer.
   Atsaves V, Leventaki V, Rassidakis GZ, Claret FX. · · 2019 · cited 227× · PMID 31340499 · DOI 10.3390/cancers11071037
4. Immune checkpoint pathways in immunotherapy for head and neck squamous cell carcinoma.
   Mei Z, Huang J, Qiao B, Lam AK. · · 2020 · cited 197× · PMID 32461587 · DOI 10.1038/s41368-020-0084-8
5. Combining Immune Checkpoint Inhibitors With Conventional Cancer Therapy.
   Yan Y, Kumar AB, Finnes H, Markovic SN, et al · · 2018 · cited 163× · PMID 30100909 · DOI 10.3389/fimmu.2018.01739
6. Combining targeted therapy with immunotherapy in BRAF-mutant melanoma: promise and challenges.
   Hu-Lieskovan S, Robert L, Homet Moreno B, Ribas A. · · 2014 · cited 150× · PMID 24958825 · DOI 10.1200/jco.2013.52.1377
7. Systemic treatments for metastatic cutaneous melanoma.
   Pasquali S, Hadjinicolaou AV, Chiarion Sileni V, Rossi CR, et al · · 2018 · cited 140× · PMID 29405038 · DOI 10.1002/14651858.cd011123.pub2
8. Cytotoxic T lymphocyte antigen-4 and immune checkpoint blockade.
   Buchbinder E, Hodi FS. · · 2015 · cited 130× · PMID 26325034 · DOI 10.1172/jci80012