A Study of RO7009789 in Combination with MPDL3280A in Patients with Locally Advanced and Metastatic Solid Tumors

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 135

Inclusion Criteria

- Histologically confirmed diagnosis of locally advanced and/or metastatic solid tumors, which are not amenable to standard therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy >/= 16 weeks
- Adequate hematologic and end organ function
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Ability to comply with the collection of tumor biopsies; tumors must be accessible for biopsy
- Agreement to use effective methods of contraception per the protocol requirements; female patients of childbearing potential must have a negative pregnancy test (urine/serum) within seven days prior to the first study drug administration
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 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

- Diagnosis of non-small cell lung cancer (NSCLC) (excluded from Part I only)
- Any approved anti-cancer therapy that includes chemotherapy, hormonal therapy, or radiotherapy within 2 weeks prior to the first dose of study treatment; the following is, allowed: Palliative radiotherapy for bone metastases - Adverse events from prior anti-cancer therapy that have not resolved to - Bisphosphonate therapy for symptomatic hypercalcemia. Use of bisphosphonate therapy for other reasons allowed. Patients receiving denosumab prior to enrollment must be willing to receive a bisphosphonate while on study.
- Uncontrolled pleural effusion, pericardial effusion, or ascites that require recurrent drainage procedures (at least one monthly). Patients with indwelling catheters are allowed.
- Known clinically significant liver disease which includes active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease
- History (within the previous year) of congestive heart failure, stroke, arrhythmia, or myocardial infarction
- History of peripheral venous thrombosis or thromboembolic event (within 12 months prior to Cycle 1 Day 1)
- Significant cardio- or cerebrovascular disease within 6 months prior to Cycle 1 Day 1
- Known hereditary or acquired coagulopathies
- Clinically meaningful proteinuria
- Requiring dialysis
- Known primary CNS malignancy or symptomatic or untreated CNS metastases: patients with asymptomatic-treated CNS metastases may be enrolled after consultation with the Medical Monitor, provided they meet the following criteria:
•Radiographic demonstration of improvement upon completion of CNS-directed therapy and no evidence of interim progression between completion of CNS-directed therapy and the screening radiographic study
•No stereotactic radiation or whole-brain radiation within 28 days prior to Cycle 1 Day 1
- Allergy or hypersensitivity to components of the RO7009789 formulation or to components of MPDL3280A formulation
- History of autoimmune diseases
- History of idiopathic pulmonary fibrosis, pneumonitis (excluding infectious disease-induced), organizing pneumonia, or evidence of active pneumonitis. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Patients with HIV infection, active hepatitis B (chronic or acute), or hepatitis C infection
- Active tuberculosis
- Severe infections within 4 weeks prior to Cycle 1 Day 1
- Signs or symptoms of infection within 2 weeks prior to Cycle 1 Day 1
- Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1. Patients receiving prophylactic antibiotics are eligible.
- Major surgical procedure within 28 days prior to Cycle 1 Day 1 or anticipation of need for a major surgical procedure during the course of the study
- Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1 or anticipation that such a live attenuated vaccine will be required during the study
- Malignancies other than disease under study within 3 years prior to Cycle 1 Day 1 with the exception of those with a negligible risk of metastasis or death and with expected curative outcome
- Prior treatment with anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody
- Previous treatment with any other compound that targets CD40
- Treatmen

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

A Study of RO7009789 in Combination with MPDL3280A in Patients with Locally Advanced and Metastatic Solid Tumors

Recruitment & Eligibility

Study & Design

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