An interventional study of MBG453 as single agent and in combination with PDR001 in patients with advanced malignancies
- Conditions
- Solid tumorsMedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-002354-12-NL
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 252
1. Histologically documented advanced or metastatic solid tumors.
2. Phase I-Ib part (including dose ranging part): Patients with advanced/metastatic solid tumors, with measurable or non measurable disease as determined by RECIST v1.1, who have progressed despite standard therapy or are intolerant to standard therapy, or for whom no standard therapy exists.
Prior therapy with PD-1/PDL-1 inhibitors is allowed provided any toxicity attributed to prior PD-1 or PD-L1-directed therapy did not lead to discontinuation of therapy and after discussion between the Investigator and Novartis study medical representative.
3. Phase II part (MBG453 single agent): Patients with advanced/metastatic solid tumors in the indication in which signs of anti-tumor activity (CR, PR or durable SD with tumor shinkrage that does not qualify for PR) were seen during the dose escalation phase I part. Patients must have measurable disease as determined by RECIST v1.1, have progressed despite standard therapy or be intolerant to standard therapy.
4. Phase II part (MBG453 in combination with PDR001): Patients with advanced/metastatic tumors in the below selected indications, with at least one measurable lesion as determined by RECIST v1.1, who have received standard therapy and are intolerant of standard therapy or have progressed following their last prior therapy.:
• Melanoma (anti-PD-1/PD-L1 therapy naïve or pre-treated)
• NSCLC (anti-PD-1/PD-L1 therapy naïve or pre-treated)
• RCC (anti-PD-1/PD-L1 therapy naïve or pre-treated)
5. 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/baseline, and during therapy on the study.
6. For MBG453 in combination with decitabine (phase Ib/II): anti-PD-1/PD-L1 therapy naïve SCLC patients who have failed no more than two lines of standard chemotherapy including topotecan.
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 187
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
1. Presence of symptomatic central nervous system (CNS) metastases.
2. History of severe hypersensitivity reactions to any ingredients of
study drugs and other monoclonal
antibodies (mAbs) and/or their excipients.
3. HBV or HCV positive patients, with active disease or whose hepatitis is
not controlled by therapy are excluded.
HIV positive patients are excluded.
4. Active autoimmune disease or a documented history of autoimmune
disease, including ulcerative colitis and Crohn's disease or any condition
that requires systemic steroids.
5. Systemic steroid therapy or any immunosuppressive therapy (=
10mg/day prednisone or equivalent).
6. Use of any vaccines against infectious diseases (e.g. varicella,
pneumococcus) within 4 weeks of initiation of study treatment.
7. Pre-treatment with anti-CTLA4 antibodies in combination with any
other antibody or drug specifically targeting T-cell co-stimulation or
checkpoint pathway.
8. Participation in an interventional, investigational non-immunotherapy
study within 2 weeks of the first dose of study treatment.
9. Prior participation in an interventional, investigational cancer vaccine
or immunotherapy study except for an anti-PD-1/PD-L1 study.
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