Clinical Trials /

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

NCT02807844

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.

Related Conditions:
  • Breast Carcinoma
  • Endometrial Carcinoma
  • Melanoma
  • Pancreatic Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title:Phase Ib/II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies
  • Official Title:A Phase Ib/II, Open Label, Multicenter Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies

Clinical Trial IDs

  • ORG STUDY ID: CMCS110Z2102
  • SECONDARY ID: 2016-000210-29
  • NCT ID: NCT02807844

Trial Conditions

  • Triple Negative Breast Cancer
  • Pancreatic Carcinoma
  • Melanoma
  • Endometrial Carcinoma

Trial Interventions

DrugSynonymsArms
MCS110Pancreatic cancer
PDR001Pancreatic cancer

Trial Purpose

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.

Detailed Description

Trial Arms

NameTypeDescriptionInterventions
Pancreatic cancerExperimental
  • MCS110
  • PDR001
Triple Negative Breast cancerExperimental
  • MCS110
  • PDR001
Endometrial CarcinomaExperimental
  • MCS110
  • PDR001
MelanomaExperimental
  • MCS110
  • PDR001

Eligibility 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.

Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Both
Healthy Volunteers:No

Primary Outcome Measures

Measure:(phase 1) Number of patients with adverse events, as a measure of safety
Time Frame:two cycles of treatment; cycle = 21 days
Safety Issue:Yes
Description:

Secondary Outcome Measures

Measure:Phase 1: Overall Response Rate (ORR)
Time Frame:6 months of treatment
Safety Issue:No
Description:
Measure:Phase 1: progression free survival (PFS)
Time Frame:6 months of treatment
Safety Issue:No
Description:
Measure:Phase 2 Overall response rate per immune related Response Criteria
Time Frame:6 months of treatment
Safety Issue:No
Description:
Measure:Phase 1 : clinical benefit rate (CBR)
Time Frame:6 months of treatment
Safety Issue:No
Description:
Measure:Phase 1 : duration of response (DOR)
Time Frame:6 months of treatment
Safety Issue:No
Description:
Measure:Phase 1 : disease control rate (DCR)
Time Frame:6 months of treatment
Safety Issue:No
Description:
Measure:Phase 2 : Progression Free Survival (PFS)
Time Frame:6 months of treatment
Safety Issue:No
Description:
Measure:Phase 2 Duration Of Response (DOR)
Time Frame:6 months of treatment
Safety Issue:No
Description:
Measure:Phase 2 : Disease Control Rate (DCR)
Time Frame:6 months of treatment
Safety Issue:No
Description:
Measure:Phase 2 : Clinical Benefit Rate (CBR)
Time Frame:6 months of treatment
Safety Issue:No
Description:

Trial Keywords

  • Triple negative breast cancer
  • Pancreatic carcinoma
  • Melanoma
  • Endometrial Carcinoma
  • Immuno oncology
  • Monoclonal antibody
  • PDR001
  • MCS110