Status:
COMPLETED
Phase I/Ib Study of GWN323 Alone and in Combination With PDR001 in Patients With Advanced Malignancies and Lymphomas
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Solid Tumors
Lymphomas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this trial is to explore the clinical utility of two investigational antibodies in patients with advanced cancer or lymphomas. This is a multi-center, open-label Phase I/Ib study. The ...
Eligibility Criteria
Inclusion
- Patients with metastatic and/or advanced solid tumors or lymphomas not amenable to curative treatment by surgery.
- Histologically documented advanced or metastatic solid tumors or lymphomas
- Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening
- ECOG Performance Status ≤ 2.
Exclusion
- Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery).
- Patients diagnosed with T-cell Lymphomas.
- Patients with prior allogenic transplants.
- Patients previously treated with anti-GITR therapy.
- History of severe hypersensitivity reactions to other mAbs.
- Patients intolerant to prior immunotherapy (unable to continue/receive due to immune-related AE).
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
July 22 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2020
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT02740270
Start Date
July 22 2016
End Date
March 3 2020
Last Update
February 21 2021
Active Locations (9)
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1
Novartis Investigative Site
Chicago, Illinois, United States, 60637
2
Novartis Investigative Site
Boston, Massachusetts, United States, 02215
3
Novartis Investigative Site
New York, New York, United States, 10017
4
Novartis Investigative Site
Houston, Texas, United States, 77030