A clinical study of the compound MCS110 in combination with the compound PDR001 in patients with advanced cancers

Phase 1

• Conditions: MedDRA version: 21.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 100000004864; advanced malignancies; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000210-29-BE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-22
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• Age = 18 years.
•Phase Ib part: Patients with advanced melanoma, endometrial carcinoma, pancreatic or triple negative breast cancer, with measurable or non-measurable disease as determined by RECIST version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
•Phase II part: Patients with advanced solid tumors with at least one measurable lesion as determined by RECIST version 1.1, who have received standard therapy or are intolerant of standard therapy, who have progressed following their last prior therapy, and fit into one of the following groups:
- Group 1: TNBC who did not receive prior anti-PD-1/PD-L1 treatment
- Group 2 : Pancreatic adenocarcinoma who did not receive prior anti-PD-1/PD-L1 treatment
- Group 3 : Endometrial carcinoma who did not receive prior anti-PD-1/PD-L1 treatment
- Group 4: Melanoma who progressed on prior PD-1- and PD-L1-directed therapies.
• ECOG Performance Status = 2.
• Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution’s guidelines. Patient must be willing to undergo a new tumor biopsy at screening, and during therapy on this study. Exceptions for patients with sites of disease not amenable to biopsy may be considered after discussion with the sponsor.

Other inclusion criteria as per protocol may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

• Presence of symptomatic CNS metastases, or CNS metastases thatrequire local CNS-directed therapy
• History of severe hypersensitivity reactions to other mAbs
• Impaired cardiac function or clinically significant cardiac disease
• Active autoimmune disease or a documented history of autoimmune disease within three years before screening
• Active infection requiring systemic antibiotic therapy
• Known history of HIV infection
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, or requiring antiviral treatment

Other exclusion criteria as per protocol may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified