NCT03555149

A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with metastatic colorectal cancer (mCRC) that became refractory to first- and second-line standard therapies. Eligible patients will be assigned to one of several treatment arms.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Regorafenib	Regorafenib will be administered orally on Days 1-21 of each 28-day cycle.
DRUG	Atezolizumab	Atezolizumab will be administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of 21-day cycles, with the exception of the Atezolizumab + Selicrelumab + Bevacizumab, Atezolizumab + Idasanutlin, Atezolizumab + Regorafenib and Atezolizumab + Regorafenib + AB928 arms where the Atezolizumab will be administered by IV infusion every 2 weeks (Q2W) on Days 1 and 15 of each 28-day cycle.
DRUG	Imprime PGG	Imprime PGG will be administered by IV infusion weekly on Days 1, 8, and 15 of each 21-day cycle.
DRUG	Bevacizumab	Bevacizumab will be administered by IV infusion on Day 1 of each 21-day cycle for the Atezolizumab + Imprime PGG + Bevacizumab arm, and on Day 1 and Day 15 of each 28-day cycle for the Atezolizumab + Selicrelumab + Bevacizumab arm.
DRUG	Isatuximab	Isatuximab will be administered on Day 1, 8 and 15 of cycle 1 and on day 1 of all subsequent cycles. Cycles will be 21 days long.
DRUG	Selicrelumab	Selicrelumab will be administered by subcutaneous (SC) injection on Day 1 of cycles 1-4 and every third cycle thereafter. Cycles will be 28 days long.
DRUG	Idasanutlin	Idasanutlin will be administered orally on Days 1-5 of each 28-day cycle.
DRUG	AB928	AB928 will be administered orally once daily on Days 1-28 of each 28-day cycle.
GENETIC	LOAd703	LOAd703 will be administered by intratumoral injection on Day 1 of each 21-day cycle.

Timeline

• Start date: 2018-09-27
• Primary completion: 2022-09-26
• Completion: 2022-09-26
• First posted: 2018-06-13
• Last updated: 2023-11-07
• Results posted: 2023-11-07

Locations

15 sites across 5 countries: United States, Australia, France, South Korea, Switzerland

Regulatory

• FDA-regulated drug study