MK-7684A With or Without Other Anticancer Therapies in Participants with Selected Solid Tumors (KEYVIBE-005)

JRCT ID: jRCT2031210335

Registered date:22/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Selected solid tumors
• Date of first enrollment: 15/10/2021
• Target sample size: 30
• Countries of recruitment: United States,Japan,Canada,Japan,France,Japan,Germany,Japan,Italy,Japan,Spain,Japan,Netherlands,Japan,Turkey,Japan,Poland,Japan,Israel,Japan,Chile,Japan,Columbia,Japan,South Korea,Japan,Taiwan,Japan
• Study type: Interventional

Intervention(s)

Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
Pembrolizumab 200 mg administered via IV infusion Q3W
Lenvatinib 20 mg, 12 mg, or 8 mg (dependent on cancer type and body weight) administered via oral capsule QD
5-FU 800 mg/m2/day administered via continuous IV infusion on each of days 1 to 5 Q3W for up to 35 cycles
Cisplatin administered via IV infusion
Paclitaxel administered via IV infusion at investigator's choice of dose
Gemcitabine administered via IV infusion on Day 1 and Day 8 of each 3-week cycle, until PD or unacceptable toxicity
Carboplatin administered via IV infusion at investigator's choice of dose and frequency
Docetaxel
For participants who cannot receive paclitaxel due to hypersensitivity or adverse event (AE), docetaxel administered via IV infusion Q3W, Day 1 of each cycle for up to 5 cycles
Bevacizumab administered via IV infusion Q3W; Day 1 of each 3-week cycle for up to 15 cycles
Capecitabine administered via oral tablet twice daily on Days 1 to 14 of each cycle (Q3W) for up to 35 cycles
Oxaliplatin administered via IV infusion Q3W up to 35 cycles

Outcome(s)

Primary Outcome

ORR per RECIST 1.1 as Assessed by BICR
PFS per RECIST 1.1 as Assessed by BICR
ORR per RECIST 1.1 as Assessed by Investigator

Secondary Outcome

Overall Survival (OS)
PFS per RECIST 1.1 as Assessed by Investigator
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
DOR per RECIST 1.1 as Assessed by Investigator
Change from Baseline in Global Health Status/Quality of Life Score
Change from Baseline in Physical Functioning Score
Number of Participants Who Experienced One or More Adverse Events (AEs)
Number of Participants Who Discontinued Study Intervention Due to an AE

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

One of the following histologically or cytologically confirmed, advanced (locally recurrent unresectable or metastatic) solid tumors:
-Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix [*recruitment completed]
-Endometrial cancer [*recruitment completed]
-Head and neck squamous cell carcinoma (HNSCC) [*recruitment completed]
-Unresectable biliary adenocarcinoma (gallbladder or biliary tree [intrahepatic or extrahepatic] cholangiocarcinoma) [*recruitment completed]
-Adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the gastroesophageal junction (GEJ). [*recruitment completed]
-Triple-negative breast cancer (TNBC) [*recruitment completed]
-Hepatocellular carcinoma (HCC) [*recruitment completed]
-Urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra
-Ovarian cancer
-Gastric cancer [*recruitment completed]
Measurable disease per RECIST v1.1 as assessed by BICR or local site investigator.
Adequately controlled blood pressure (BP) with or without antihypertensive medications.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
Male participants must agree to follow contraceptive guidance.
Female participants are not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance.
Adequate organ function.

Exclude criteria

History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
Prior therapy with anti-programmed cell-death (PD-1), anti-PD-L1, anti-PD-L2, or anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) agent.
Prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study medication.
Active autoimmune disease that has required systemic treatment in past 2 years.
Active infection requiring systemic therapy.
Concurrent active Hepatitis B and Hepatitis C virus infection.
History of allogenic tissue/solid organ transplant.
Previous treatment with lenvatinib (for participants who will receive lenvatinib in their assigned treatment arm).
Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.

Related Information

• Primary Sponsor: Koh Yasuhiro
• Secondary ID(s): NCT05007106