Phase Ib/II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Skin Cancer, Cervical Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/13/2018 |
| Start Date: | June 29, 2016 |
| End Date: | May 15, 2019 |
| Contact: | Novartis Pharmaceuticals |
| Email: | Novartis.email@novartis.com |
| Phone: | 1-888-669-6682 |
A Phase Ib/II, Open Label, Multicenter Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies
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.
pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of the combination of
MCS110 with PDR001 in adult patients with solid tumors.
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.
We found this trial at
5
sites
Houston, Texas 77030
Principal Investigator: Aung Naing
Phone: 713-792-0007
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Boston, Massachusetts 02118
Principal Investigator: F Stephen Hodi
Phone: 617-643-1820
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