A Study Evaluating TAS-102 Plus Nivolumab in Patients With MSS CRC

Conditions

• Refractory Metastatic Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TAS-102 — DRUG
  One Arm Only (of TAS 102 plus nivolumab)
• nivolumab — DRUG
  One Arm Only (of TAS 102 plus nivolumab)

Study Details

A Phase 2 Study with Safety Lead-in, Evaluating TAS-102 Plus Nivolumab in Participants with Microsatellite Stable Refractory Metastatic Colorectal Cancer

Key Dates

Start date

Aug 29, 2016

Status verified

Aug 2024

Primary completion

Aug 31, 2017

Completion

Sep 7, 2017

Study Design

Enrollment

18 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: TAS-102 + Nivolumab
  Participants received a dose of 35 milligrams per meter square (mg/m\^2) of TAS-102 tablets orally twice per day (BID) within 1 hour after completion of morning and evening meals, in 4-week cycle. In each 4-week cycle, TAS-102 was administered for 2 weeks, as 5 days a week with 2 days rest, followed by a 14-day rest. Also participants received 3 milligrams per kilogram per dose (mg/kg/dose) Nivolumab intravenous (I.V) infusion over 60 minutes every 14 days (on Day 1 and Day 15 of each 4-week cycle).

Primary Outcome Measure

Immune-Related Overall Response Rate (irORR) [ Time Frame: From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) ]

Locations (3)

Find similar trials in Denver, CO

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