PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer

NCT03176264 | Terminated Phase 1 FDA Drug

• 2 other identifiers: CPDR001I21012017-000520-96
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This was a phase Ib study of PDR001 in combination with bevacizumab and mFOLFOX6 as first line therapy in patients with metastatic microsatellite stable (MSS) colorectal cancer. The study was to have assessed primarily, the safety and tolerability and then the efficacy of PDR001 in combination with bevacizumab and mFOLFOX6. Particular attention would have been paid to the level of activity of study drug combinations in CMS4 patients (retrospective analysis). The study was terminated early due to company decision.

Conditions

Metastatic Colorectal Cancer

Keywords

PDR001; immunotherapy; bevacizumab; mFOLFOX6; CRC; MMS; CMS4; ElevatION;CRC-101

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose-limiting toxicity (DLT)

  12 months

• Overall Response Rate (ORR) per investigator assessment using RECIST v1.1

  RECIST v1.1 = Response Evaluation Criteria in Solid Tumors v1.1

  19 months

Secondary Outcomes (10)

• Overall response rate (ORR) per central assessment using RECIST v1.1

  Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit

• Overall survival (OS)

  Every 3 months after last visit up to 1 year after last patient last visit

• Progression free survival

  Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit

• Duration of response (DOR)

  Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit

• Disease control rate (DCR)

  Baseline, every 8 weeks until progression per central assessment up to 1 year after last patient last visit

Study Arms (1)

PDR001

EXPERIMENTAL

Drug: PDR001; Drug: bevacizumab; Drug: mFOLFOX6

Interventions

PDR001 DRUG

400 mg every 4 weeks

PDR001

bevacizumab DRUG

5 mg/kg every 2 weeks

PDR001

mFOLFOX6 DRUG

Combination of chemotherapy administered every 2 weeks: oxaliplatin (85mg/m2), 5-Fluorouracil (2400mg/m2) and folinic acid (=leucovorin, 400mg/m2)

PDR001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with metastatic MSS colorectal adenocarcinoma.Note: MSI status will be performed locally by an immunohistochemistry (IHC) or PCR based test for eligibility.
• Patients must provide a newly obtained or an archival tumor sample corresponding to CRC diagnosis (primary tumor) with sufficient tissue quality (qualified) for analysis (mandatory)
• Patients must provide a newly obtained tumor tissue sample from a metastatic site (mandatory)
• Patients with the presence of at least one lesion with measurable disease as per RECIST 1.1 guidelines. Lesions in previously irradiated areas should not be considered measurable unless they have clearly progressed since the radiotherapy.
• \. Patients have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1

You may not qualify if:

• Patients with MSI-H colorectal adenocarcinoma as defined per local assessment using standard of care testing
• Patients with metastatic disease amenable to be resected with potentially curative surgery
• Patients who have received any systemic treatment for metastatic disease.
• Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PDL2, anti-CTLA-4 antibodies, other checkpoint inhibitors
• Patients who had received radiation within 14 days prior to the first dose of study drug

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Related Links

• Novartis results database
• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

spartalizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase Ib study, safety run-in (N=\~6 pts) followed with an expansion (N=\~86 pts). One single arm: PDR001 in combination with bevacizumab and mFOLFOX6

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: June 5, 2017
• Study Start: September 25, 2017
• Primary Completion: January 30, 2018
• Study Completion: January 30, 2018
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)