A phase I-Ib/II, open-label, multi-center study of the safety and efficacy of MBG453 as single agent and in combination with PDR001 in adult patients with advanced malignancies
- Conditions
- advanced cancerlungcancermelanoma10027655
- Registration Number
- NL-OMON53097
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 33
* Phase I-Ib part: Advanced/metastatic solid tumors, with (non)-measurable
disease, who have progressed despite standard therapy or are intolerant of
standard therapy, or for whom no standard therapy exists, and who did not
receive prior anti-PD1/PD-L1 treatment. 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.
* Phase II single agent part: 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 phase I. Patients must have measurable
disease, have progressed despite standard therapy or be intolerant to standard
therapy.
* Phase II part combination therapy: Advanced/metastatic solid tumors, with at
least one measurable lesion, who have received standard therapy or are
intolerant of standard therapy, have progressed following their last prior
therapy, and fit into one of the following groups: non-small cell lung cancer
or melanoma pretreated with anti-PD-1/PD-L1 therapy.
* ECOG performance status 0-1-2.
* Disease amenable to biopsy and a candidate for tumor biopsy according to the
treating institution*s guidelines. Patient must be willing to undergo a new
tumor biopsy at baseline, and during therapy on this study.
* Symptomatic CNS metastases or CNS metastases that require local CNS-directed
therapy or increasing doses of corticosteroids within the prior 2 weeks.
Patients with treated brain metastases should be neurologically stable
* Out of range laboratory values.
* Impaired cardiac function or clinically significant cardiac disease.
* HBV or HCV positive patients, with active disease or whose hepatitis is not
controlled by therapy are excluded. HIV positive patients are excluded.
* Active autoimmune disease or history of autoimmune disease
* Any condition that requires systemic steroids
* Systemic anti-cancer therapy within 2-4 weeks of the first dose of study
treatment.
* Vaccines against infectious diseases within 4 weeks of initiation of study
treatment.
* Major surgery within 2 weeks.
* Radiotherapy within 2 weeks, except for palliative radiotherapy to a limited
field.
* Use of hematopietic growth factors (CSF) within 2 weeks.
* Prior participation in an interventional, investigational cancer vaccine or
immunotherapy study except for an anti-PD-1/PD-L1 study.
* Participation in another type of interventional study in the last 2 weeks.
For details refer to protocol page 35-36
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Phase I:<br /><br>Safety: Incidence and severity of (S)AEs, including changes in laboratory<br /><br>parameters, vital signs and ECGs<br /><br>Tolerability: Dose interruptions, reductions and dose intensity<br /><br>Incidence of DLTs during the first cycle of treatment with single agent MBG453<br /><br>and during the first and second cycle of treatment with MBG453 in combination<br /><br>with PDR001.<br /><br><br /><br>Phase II: Overall Response Rate (ORR) per RECIST 1.1</p><br>
- Secondary Outcome Measures
Name Time Method <p><br /><br>Phase I: Best Overall response (BOR), Progressive Free Survival (PFS), Duration<br /><br>of Response (DOR) per RECIST 1.1 and Overall Response Rate (ORR) and<br /><br>Progressive Free Survival (PFS) per iRC<br /><br><br /><br>Phase II: Safety: Incidence and severity of (S)AEs, including changes in<br /><br>laboratory parameters, vital signs and ECGs<br /><br>Tolerability: Dose interruptions, reductions and dose intensity<br /><br>Overall Response Rate (ORR), Best Overall response (BOR), Progressive Free<br /><br>Survival (PFS), Duration of Response (DOR) per RECIST 1.1 Overall Response Rate<br /><br>(ORR) and Progressive Free Survival (PFS) per iRC</p><br>