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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.
 
ClinicalTrials.gov Identifier: NCT02807844
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : February 27, 2020
Sponsor:
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

Detailed Description:
Combined treatment with MCS110 and PDR001 is expected to result in TAM depletion, enhanced T-cell activation and synergistic antitumor activity in the clinical setting.

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Study Type : Interventional
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 : March 27, 2020
Estimated Study Completion Date : March 29, 2020


Arm Intervention/treatment
Experimental: Pancreatic cancer
Pancreatic adenocarcinoma who did not receive prior anti-PD-1/PD-L1 treatment
Drug: MCS110
Drug: PDR001
Experimental: Triple Negative Breast cancer
TNBC who did not receive anti-PD-1/PD-L1 treatment
Drug: MCS110
Drug: PDR001
Experimental: Endometrial Carcinoma
Endometrial carcinoma who did not receive Prior anti-PD-1/PD-L1 treatment
Drug: MCS110
Drug: PDR001
Experimental: Melanoma
Melanoma who progressed on Prior PD-1 and PD-L1 directed therapies
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 ]
    To characterize the safety and tolerability of MCS110 in combination with PDR001 in patients with advanced solid malignancies and to identify a recommended dose combination for Phase II

  2. (phase 2) : Overall Response rate (ORR) [ Time Frame: 4 years ]
    To estimate the anti-tumor activity of the combination of MCS110 with PDR001


Secondary Outcome Measures :
  1. Phase 1: Overall Response Rate (ORR) [ Time Frame: 4 years ]
    Per RECIST v1.1 and per immune related Response criteria (irRC)

  2. Phase 1: progression free survival (PFS) [ Time Frame: 4 years ]
    Per RECIST v1.1 and per immune related Response criteria (irRC)

  3. Phase 2 Overall response rate per Response Criteria [ Time Frame: 4 years ]
    Per RECIST v1.1 and per immune related Response criteria (irRC)

  4. Phase 1 : clinical benefit rate (CBR) [ Time Frame: 4 years ]
    Per RECIST v1.1 and per immune related Response criteria (irRC)

  5. Phase 1 : duration of response (DOR) [ Time Frame: 4 years ]
    Per RECIST v1.1 and per immune related Response criteria (irRC)

  6. Phase 1 : disease control rate (DCR) [ Time Frame: 4 years ]
    Per RECIST v1.1 and per immune related Response criteria (irRC)

  7. Phase 2 : Progression Free Survival (PFS) [ Time Frame: 4 years ]
    Per RECIST v1.1 and per immune related Response criteria (irRC)

  8. Pharmacokinetics of MCS110 and PDR001 in combination [ Time Frame: 4 years ]
    Serum concentration of MCS110 and PDR001, and PK Parameters (AUC, Cmax, Clast, T1/2, Tmax, CL, Vz, AR)

  9. Phase 2 Duration Of Response (DOR) [ Time Frame: 4 years ]
    Per RECIST v1.1 and per immune related Response criteria (irRC)

  10. Phase 2 : Disease Control Rate (DCR) [ Time Frame: 4 years ]
    Per RECIST v1.1 and per immune related Response criteria (irRC)

  11. Phase 2 : Clinical Benefit Rate (CBR) [ Time Frame: 4 years ]
    Per RECIST v1.1 and per immune related Response criteria (irRC)

  12. Immunogenicity PDR001 [ Time Frame: 4 years ]
    Presence and/or concentration of anti-PDR001 antibodies

  13. Immunogenicity MCS110 [ Time Frame: 4 years ]
    Presence and/or concentration of anti-MCS110 antibodies



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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 ClinicalTrials.gov identifier (NCT number): NCT02807844


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, Massachusetts
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02215
Contact: Janice Russell    617-643-1820    Janice_Russell@DFCI.Harvard.edu   
Principal Investigator: F Stephen Hodi         
United States, Missouri
Novartis Investigative Site Completed
Saint Louis, Missouri, United States, 63123
United States, Tennessee
Novartis Investigative Site Completed
Germantown, Tennessee, United States, 38138
United States, Texas
Novartis Investigative Site Active, not recruiting
Houston, Texas, United States, 77030
Belgium
Novartis Investigative Site Completed
Wilrijk, Belgium, 2610
Finland
Novartis Investigative Site Recruiting
HUS, Finland, FIN-00029
France
Novartis Investigative Site Active, not recruiting
Saint Herblain cedex, France, 44805
Germany
Novartis Investigative Site Active, not recruiting
Frankfurt, Germany, 60590
Novartis Investigative Site Active, not recruiting
Ulm, Germany, 89081
Hong Kong
Novartis Investigative Site Active, not recruiting
Hong Kong, Hong Kong
Italy
Novartis Investigative Site Active, not recruiting
Milano, MI, Italy, 20133
Novartis Investigative Site Active, not recruiting
Milano, MI, Italy, 20141
Japan
Novartis Investigative Site Completed
Koto ku, Tokyo, Japan, 135 8550
Korea, Republic of
Novartis Investigative Site Completed
Seoul, Korea, Republic of, 03080
Novartis Investigative Site Active, not recruiting
Seoul, Korea, Republic of, 05505
Spain
Novartis Investigative Site Active, not recruiting
Valencia, Comunidad Valenciana, Spain, 46010
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28009
Switzerland
Novartis Investigative Site Completed
Chur, Switzerland, 7000
Novartis Investigative Site Completed
Geneve 14, Switzerland, CH 1211
Novartis Investigative Site Active, not recruiting
Zuerich, Switzerland, 8091
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02807844    
Other Study ID Numbers: CMCS110Z2102
2016-000210-29 ( EudraCT Number )
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
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 www.clinicalstudydatarequest.com


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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
Melanoma
Endometrial Carcinoma
Immuno oncology
Monoclonal antibody
PDR001
MCS110
Additional relevant MeSH terms:
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Triple Negative Breast Neoplasms
Endometrial Neoplasms
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Breast Neoplasms
Neoplasms by Site
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Digestive System Neoplasms
Endocrine Gland Neoplasms
Carcinoma
Melanoma
Breast Diseases
Skin Diseases
Nevi and Melanomas
Uterine Diseases
Genital Diseases, Female
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases