Phase I/Ib study of GWN323 alone and in combination with PDR001 in patients with advanced malignancies and lymphomas
- Conditions
- Solid tumors and lymphomasTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-004206-42-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 264
- 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.
Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 204
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
- 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 exclusion criteria may apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method