Health TrialsbyHealthPanel

TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

ConditionColorectal Cancer; Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTeclison Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Prior organ transplantation

Liver metastasis more than 50%

Oxygen saturation less than 92% in room air

Prior autoimmune disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: colorectal cancerExperimental treatment 3 interventions
Group B: NSCLCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival for the mCRC cohort

From the first day of treatment to death

Time frame
24 months
2

Overall Response Rate (ORR) for the NSCLC cohort

Per RECIST 1.1 criteria

Time frame
within 24 months

Secondary outcomes

1

Duration of Response

per RECIST 1.1

Time frame
24 months
2

Response rate

in TATE treated or TATE-untreated lesions by RECIST and mRECIST

Time frame
24 months
3

PFS

Progression Free Survival

Time frame
24 months
4

TTP

Time to Progression

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Teclison Ltd.

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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