A Study of TAK-659 in Combination With Nivolumab in Participants With Advanced Solid Tumors

Summary

The purpose of this study is to evaluate the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), safety and efficacy of TAK-659 in combination with nivolumab in participants with advanced solid tumors.

Timeline

Start

2016-08-12

Primary completion

2018-11-30

Completion

2018-11-30

Outcome

Mixed primary results

Stopped: “Insufficient efficacy of drug; no safety concern”

paper The dose-escalation phase evaluated the recommended phase II dose (RP2D; primary endpoint). PMID 38501219 ↗

paper The determined RP2D was once-daily mivavotinib 80 mg plus nivolumab 3 mg/kg. PMID 38501219 ↗

paper The expansion phase evaluated overall response rate (primary end point) at the RP2D in patients with triple-negative breast cancer (TNBC). PMID 38501219 ↗

paper The expansion phase was terminated at ~50% enrollment (n = 17) after failing to meet an ad hoc efficacy futility threshold. PMID 38501219 ↗

Publications

• Juric D, Barve M, Vaishampayan U, Roda D, Calvo A, Janez NM, Trigo J, Greystoke A, Harvey RD, Olszanski AJ, Opyrchal M, Spira A, Thistlethwaite F, Jimenez B, Sappal JH, Kannan K, Riley J, Li C, Li C, Gregory RC, Miao H, Wang S. A phase Ib study evaluating the recommended phase II dose, safety, tolerability, and efficacy of mivavotinib in combination with nivolumab in advanced solid tumors. Cancer Med. 2024 Mar;13(5):10.1002/cam4.6776. doi: 10.1002/cam4.6776.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Nivolumab	Monoclonal antibody	240 mg	Intravenous
Subject	mivavotinib	Small molecule	60 mg	Oral
Subject	mivavotinib	Small molecule	80 mg	Oral
Subject	mivavotinib	Small molecule	100 mg	Oral

Indications