TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

Conditions

• Colorectal Cancer; Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TATE and pembrolizumab — DRUG
  All 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 pill — DRUG
  The comparator of the mCRC arm is TAS-102 at 60 mg BID 5 days per week for 2 weeks then 2 weeks off.
• Regorafenib Pill — DRUG
  As 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.

Study Details

Patients with refractory metastatic colorectal cancer or non-small cell lung cancer with liver metastasis treated with Trans-arterial Tirapazamine Embolization along with Pembrolizumab.

Key Dates

Start date

May 20, 2021

Status verified

Apr 2026

Primary completion

Mar 31, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

110 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: colorectal cancer
  metastatic colorectal cancer progressed on at least two lines of chemotherapy
• Experimental: NSCLC
  Liver metastatic NSCLC progressed on immune checkpoint inhibitors and chemotherapy

Primary Outcome Measure

Overall Survival for the mCRC cohort [ Time Frame: 24 months ]

Central Contacts

• Ray Lee, MD. PhD.
  8043341076
  [email protected]
• Chiwei Lu
  [email protected]

Locations (1)

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