A Trial of CXD101 in Combination With Nivolumab in Patients With Metastatic Microsatellite-Stable Colorectal Cancer

Sponsor
Celleron Therapeutics Ltd.
Study ID
NCT03993626
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Colorectal Neoplasms Malignant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a study to assess the safety and efficacy of CXD101 in combination with the PD-1 Inhibitor Nivolumab in patients with metastatic, previously-treated, Microsatellite-Stable (MSS) Colorectal Carcinoma (CRC). The primary hypothesis of this study is that CXD101 and anti-PD1 monoclonal antibody synergise the anti-tumour activity in MSS colorectal cancer patients (\~95% of CRC) who do not seem to respond to anti-PD1 or -PD-L1 immunotherapy alone.

Key Dates

Start date
May 22, 2018
Status verified
Jun 2019
Primary completion
Dec 15, 2019
Completion
Jun 15, 2020

Study Design

Enrollment
55 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CXD101 and Nivolumab combination
    * CXD101 will be presented as 10mg HPMC capsules and will be taken orally for 5 consecutive days repeated every three weeks on an outpatient basis. * Nivolumab will be presented as a 10 mg/mL solution in a single-dose vial, administered as iv infusion over 60 mins, repeated every two weeks. * CXD101 in combination with nivolumab will be administered in the Phase II component of the trial at doses determined in the Phase Ib component.

Primary Outcome Measure

Immune Disease Control Rate (iDCR) [ Time Frame: 6 months ]

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