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TATE and pembrolizumab

Phase 2

Colorectal Cancer; Lung Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Apr 16, 2026

Development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jan 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

Clinical trial landscape

TATE and pembrolizumab · 1 trial · 1 indication

Phase 2 1
NCT04701476TATE and Pembrolizumab (MK3475) in mCRC and NSCLCColorectal Cancer; Lung Cancer
RECRUITING110 Analytics
PHASE2RECRUITING
TATE and Pembrolizumab (MK3475) in mCRC and NSCLC
Colorectal Cancer; Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Survival for the mCRC cohort
24 months

From the first day of treatment to death

Overall Response Rate (ORR) for the NSCLC cohort
within 24 months

Per RECIST 1.1 criteria

Secondary Endpoints

Duration of Response
24 months
Response rate
24 months
PFS
24 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
colorectal cancerEXPERIMENTALmetastatic colorectal cancer progressed on at least two lines of chemotherapy
NSCLCEXPERIMENTALLiver metastatic NSCLC progressed on immune checkpoint inhibitors and chemotherapy

Interventions

NameTypeDescription
TATE and pembrolizumabDRUGAll liver metastatic lesions will be treated with TATE for maximally debulking. Pembrolizumab IV infusion per standard schedule every 3 or 6 weeks until progression or maximally 2 years.
TAS-102 pillDRUGThe comparator of the mCRC arm is TAS-102 at 60 mg BID 5 days per week for 2 weeks then 2 weeks off.
Regorafenib PillDRUGAs an alternative to TAS-102 per treating physician's discretion. If selected, Regorafenib 160 mg oral daily for 3 weeks on and one week off, every 4 weeks per cycle. Do not take Regoarefnib if taking TAS-102.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Liver metastatic MSS-mCRC or NSCLC without EGFR or AKT mutations * mCRC progressed on at least two lines of standard chemotherapy; or * NSCLC progressed on chemotherapy and an immune checkpoint inhibitor * Measurable disease * ECOG 0-1 * At least 4 weeks from prior chemotherap...

Countries:United StatesTaiwan
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