An interventional study of MBG453 alone and in combination with PDR001 in patients with advanced malignancies

Phase 1

• Conditions: Solid tumors; MedDRA version: 20.0Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.1Level: PTClassification code 10073251Term: Clear cell renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: HLTClassification code 10029111Term: Neoplasms unspecified malignancy and site unspecified NECSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002354-12-IT
• Lead Sponsor: OVARTIS FARMA S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-20
• Last Update Posted: 27 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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 of standard therapy, or for whom no standard therapy exists and who did not receive prior anti-PD1/PD-L1 treatment.
3. Phase II part (MBG453 single agent): Patients with advanced/metastatic solid tumors in the indication in which at least one confirmed PR or CR was 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 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.
Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 175
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

1. Presence of symptomatic central nervous system (CNS) metastases.
2. History of severe hypersensitivity reactions to other monoclonal antibodies (mAbs).
3. Human Immunodeficiency Virus (HIV), HBV (Hepatitis B Virus) or HCV (Hepatitis C Virus) infection.
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