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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02807844
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : July 17, 2019
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Pancreatic Carcinoma Melanoma Endometrial Carcinoma Drug: MCS110 Drug: PDR001 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib/II, Open Label, Multicenter Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies
Actual Study Start Date : June 29, 2016
Estimated Primary Completion Date : November 15, 2019
Estimated Study Completion Date : November 17, 2019

Arm Intervention/treatment
Experimental: Pancreatic cancer Drug: MCS110
Drug: PDR001
Experimental: Triple Negative Breast cancer Drug: MCS110
Drug: PDR001
Experimental: Endometrial Carcinoma Drug: MCS110
Drug: PDR001
Experimental: Melanoma Drug: MCS110
Drug: PDR001

Primary Outcome Measures :
  1. (phase 1) Number of patients with adverse events, as a measure of safety [ Time Frame: two cycles of treatment; cycle = 21 days ]
  2. (phase 2) : Overall Response rate (ORR) [ Time Frame: 6 months of treatment ]

Secondary Outcome Measures :
  1. Phase 1: Overall Response Rate (ORR) [ Time Frame: 6 months of treatment ]
  2. Phase 1: progression free survival (PFS) [ Time Frame: 6 months of treatment ]
  3. Phase 2 Overall response rate per immune related Response Criteria [ Time Frame: 6 months of treatment ]
  4. Phase 1 : clinical benefit rate (CBR) [ Time Frame: 6 months of treatment ]
  5. Phase 1 : duration of response (DOR) [ Time Frame: 6 months of treatment ]
  6. Phase 1 : disease control rate (DCR) [ Time Frame: 6 months of treatment ]
  7. Phase 2 : Progression Free Survival (PFS) [ Time Frame: 6 months of treatment ]
  8. Phase 2 Duration Of Response (DOR) [ Time Frame: 6 months of treatment ]
  9. Phase 2 : Disease Control Rate (DCR) [ Time Frame: 6 months of treatment ]
  10. Phase 2 : Clinical Benefit Rate (CBR) [ Time Frame: 6 months of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02807844

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Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111

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United States, Massachusetts
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02215
Contact: Janice Russell    617-643-1820   
Principal Investigator: F Stephen Hodi         
United States, Missouri
Novartis Investigative Site Recruiting
Saint Louis, Missouri, United States, 63123
United States, Tennessee
Novartis Investigative Site Recruiting
Germantown, Tennessee, United States, 38138
United States, Texas
Novartis Investigative Site Recruiting
Houston, Texas, United States, 77030
Contact: Lacey McQuinn    713-792-0007   
Principal Investigator: Aung Naing         
Novartis Investigative Site Completed
Wilrijk, Belgium, 2610
Novartis Investigative Site Recruiting
HUS, Finland, FIN-00029
Novartis Investigative Site Recruiting
Saint Herblain cedex, France, 44805
Novartis Investigative Site Recruiting
Frankfurt, Germany, 60590
Novartis Investigative Site Recruiting
Ulm, Germany, 89081
Hong Kong
Novartis Investigative Site Recruiting
Hong Kong, Hong Kong
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20133
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20141
Novartis Investigative Site Recruiting
Koto ku, Tokyo, Japan, 135 8550
Korea, Republic of
Novartis Investigative Site Recruiting
Seoul, Korea, Republic of, 03080
Novartis Investigative Site Recruiting
Seoul, Korea, Republic of, 05505
Novartis Investigative Site Recruiting
Valencia, Comunidad Valenciana, Spain, 46010
Novartis Investigative Site Recruiting
Madrid, Spain, 28009
Novartis Investigative Site Recruiting
Chur, Switzerland, 7000
Novartis Investigative Site Recruiting
Geneve 14, Switzerland, CH 1211
Novartis Investigative Site Recruiting
Zuerich, Switzerland, 8091
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals Identifier: NCT02807844     History of Changes
Other Study ID Numbers: CMCS110Z2102
2016-000210-29 ( EudraCT Number )
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Triple negative breast cancer
Pancreatic carcinoma
Endometrial Carcinoma
Immuno oncology
Monoclonal antibody
Additional relevant MeSH terms:
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Triple Negative Breast Neoplasms
Endometrial Neoplasms
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases