NCT02631447: SECOMBIT

Sequential Combo Immuno and Target Therapy (SECOMBIT) Study

Completed Phase 2 Last updated 7 June 2024

What this trial tests

Phase 2 trial testing LGX818 in Metastatic Melanoma in 251 participants. Completed in 31 May 2024.

Timeline

14 November 2016

Primary endpoint
31 May 2024

31 May 2024

Quick facts

Lead sponsor	Fondazione Melanoma Onlus
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	251
Start date	14 November 2016
Primary completion	31 May 2024
Estimated completion	31 May 2024
Sites	30 locations across France, Italy, Greece, Austria, Sweden, United Kingdom, Germany, Poland

Drugs / interventions tested

• LGX818 (lgx818) — full drug profile →
• MEK162 (mek162) — full drug profile →
• Nivolumab (nivolumab) — full drug profile →
• Ipilimumab — full drug profile →

Conditions studied

• Metastatic Melanoma — all drugs for Metastatic Melanoma →

Sponsor

Fondazione Melanoma Onlus — full company profile →

Who can join

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

Sponsor's own description

To evaluate the best sequencing approach with the combination of target agents (LGX818 plus MEK162) and the combination of immunomodulatory antibodies (ipilimumab plus nivolumab) in patients with metastatic melanoma and BRAF V600 mutation.

Publications & conference data

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

1. Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma.
   Wolchok JD, Chiarion-Sileni V, Gonzalez R, Grob JJ, et al · · 2022 · cited 862× · PMID 34818112 · DOI 10.1200/jco.21.02229
2. Melanoma treatment in review.
   Domingues B, Lopes JM, Soares P, Pópulo H. · · 2018 · cited 432× · PMID 29922629 · DOI 10.2147/itt.s134842
3. 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
4. Sequencing of Ipilimumab Plus Nivolumab and Encorafenib Plus Binimetinib for Untreated <i>BRAF</i>-Mutated Metastatic Melanoma (SECOMBIT): A Randomized, Three-Arm, Open-Label Phase II Trial.
   Ascierto PA, Mandalà M, Ferrucci PF, Guidoboni M, et al · · 2023 · cited 183× · PMID 36049147 · DOI 10.1200/jco.21.02961
5. Managing Metastatic Melanoma in 2022: A Clinical Review.
   Switzer B, Puzanov I, Skitzki JJ, Hamad L, et al · · 2022 · cited 144× · PMID 35133862 · DOI 10.1200/op.21.00686
6. Randomized Phase III Trial Evaluating Spartalizumab Plus Dabrafenib and Trametinib for <i>BRAF</i> V600-Mutant Unresectable or Metastatic Melanoma.
   Dummer R, Long GV, Robert C, Tawbi HA, et al · · 2022 · cited 141× · PMID 35030011 · DOI 10.1200/jco.21.01601
7. Tumor mutation burden and circulating tumor DNA in combined CTLA-4 and PD-1 antibody therapy in metastatic melanoma - results of a prospective biomarker study.
   Forschner A, Battke F, Hadaschik D, Schulze M, et al · · 2019 · cited 138× · PMID 31300034 · DOI 10.1186/s40425-019-0659-0
8. KEYNOTE-022 part 3: a randomized, double-blind, phase 2 study of pembrolizumab, dabrafenib, and trametinib in <i>BRAF</i>-mutant melanoma.
   Ferrucci PF, Di Giacomo AM, Del Vecchio M, Atkinson V, et al · · 2020 · cited 137× · PMID 33361337 · DOI 10.1136/jitc-2020-001806