Phase Ib/II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies

Description

The purpose of this study of MCS110 with PDR001 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of the combination of MCS110 with PDR001 in adult patients with solid tumors.

Study Start Date

June, 29 2016

Estimated Completion Date

June 2019

Interventions

  • Drug: PDR001
  • Drug: MCS110

Study ID

Novartis -- CMCS110Z2102

Status

Recruiting

Trial ID

NCT02807844

Study Type

Interventional

Trial Phase

Phase 1/Phase 2

Enrollment Quota

175

Sponsor

Novartis

Inclusion Criteria

  • Signed informed consent prior to any procedures
  • Patients with advanced melanoma, endometrial carcinoma, pancreatic or TNBC, with measurable or non-measurable disease who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.

Exclusion Criteria

  • Patient having out of range laboratory values defined as:
  • Creatinine clearance < 40 mL/min
  • Total bilirubin > 1.5 x ULN
  • Absolute neutrophil count < 1.0 x 109/L
  • Hemoglobin (Hgb) < 9 g/dL
  • Impaired cardiac function or clinically significant cardiac disease
  • Active autoimmune disease
  • Malignant disease, other than that being treated in this study.
  • Presence of ? CTCAE Grade 2 toxicity due to prior cancer therapy.
  • Pregnant or lactating women Other protocol-defined inclusion/exclusion may apply.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (7)

Study Location Distance Name Phone Email
Dana Farber Cancer Center - Boston, Massachusetts 2.4 miles Janice Russell 617-643-1820 Janice_Russell@DFCI.Harvard.edu
Dana Farber Cancer Center - Boston, Massachusetts 2.4 miles Janice Russell 617-643-1820 Janice_Russell@DFCI.Harvard.edu
Dana Farber Cancer Center - Boston, Massachusetts 2.4 miles Janice Russell 617-643-1820 Janice_Russell@DFCI.Harvard.edu
MD Anderson Cancer Center - Houston, Texas 1,609.9 miles Lacey McQuinn 713-792-0007 lmcquinn@mdanderson.org
MD Anderson Cancer Center - Houston, Texas 1,609.9 miles Lacey McQuinn 713-792-0007 lmcquinn@mdanderson.org
MD Anderson Cancer Center - Houston, Texas 1,609.9 miles Lacey McQuinn 713-792-0007 lmcquinn@mdanderson.org
MD Anderson Cancer Center - Houston, Texas 1,609.9 miles Lacey McQuinn 713-792-0007 lmcquinn@mdanderson.org

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