EUCTR2015-001879-43-ESActive, not recruitingPhase 1
A Phase 1b/2, Open-Label, Dose-Finding Study to Evaluate Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Avelumab (MSB0010718C) in Combination with Either Crizotinib or PF-06463922 in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer
Pfizer Inc, 235 East 42nd Street, New York, NY 100170 sites43 target enrollmentStarted: January 13, 2016Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 43
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Diagnosis.
- •Histologically or cytologically proven diagnosis of NSCLC that is locally advanced
- •or metastatic:
- •- Group A: ALK-negative NSCLC based on locally approved testing. No known
- •ROS1 or c-MET alterations predicted to confer sensitivity to crizotinib (testing is not required if not locally available). EGFR mutations must also have been evaluated based on locally approved testing. Patients with EGFR mutation positive NSCLC will be permitted onto this study group if standard treatment options for EGFR mutation positive NSCLC have been exhausted.
- •- Group B: ALK-positive NSCLC based on locally approved testing.
- •2. Mandatory archival FFPE tumor tissue. If tissue is unavailable, a mandatory tumor biopsy must be performed.
- •3. At least one measurable lesion as defined by RECIST v.1.1 that has not previously been irradiated.
- •4. Age = or >18 years (>20 years for Japan).
- •5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
- •6. Estimated life expectancy of at least 3 months.
- •7. Adequate Bone Marrow Function, including:
- •a. Absolute Neutrophil Count (ANC) = or > 1,500/mm3 or = or >1.5 x 109/L;
- •b. Platelets = or >100,000/mm3 or = or >100 x 109/L;
- •c. Hemoglobin = or > 9 g/dL (may have been transfused).
- •8. Adequate Renal Function as evidenced by:
- •a. Estimated creatinine clearance = or > 50 mL/min as calculated using the
- •Cockcroft-Gault equation.
- •9. Adequate Liver Function, including:
- •a. Total serum bilirubin = or >1.5 x ULN;
- •b. Aspartate and alanine aminotransferase (AST and ALT) = or >2.5 x ULN; in all patients.
- •10. Adequate Pancreatic Function, including:
- •a. Serum amylase < 1.5 x ULN;
- •b. Serum lipase < 1.5 x ULN.
- •11. INR or prothrombin time (PT) <1.5 x ULN.
- •12. Serum pregnancy test (for females of childbearing potential) negative at screening.
- •13. Male patients able to father children and female patients of childbearing potential and at risk for pregnancy must agree to use 2 highly effective methods of contraception throughout the study and for at least 90 days after the last dose of assigned treatment.
- •14. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- •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 68
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 68
Exclusion Criteria
- •1. Patients with any of the following characteristics/conditions will not be included in the study: Major surgery ?4 weeks or radiation therapy = or >2 weeks prior to study entry. Prior palliative radiotherapy (= or > 10 fractions) to metastatic lesion(s) is permitted, provided it has been completed 48 hours prior to patient registration.
- •2. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways).
- •3. Systemic anti-cancer therapy = or >2 weeks prior to study entry.
- •4. Brain metastases, except:
- •- Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable (Group A).
- •- Patients with asymptomatic brain metastases currently requiring no steroids (Group B).
- •5. Persisting NCI CTCAE v4.0 Grade >1 toxicity related to prior therapy; however, alopecia Grade 2 is acceptable.
- •6. Diagnosis of any other malignancy within 5 years prior to study entry, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix, or low-grade (Gleason 6 or below) prostate cancer on surveillance without any plans for treatment intervention (eg, surgery, radiation, or castration).
- •7. Current or prior use of immunosuppressive medication within 7 days prior to randomization, except the following: Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection); Systemic corticosteroids at physiologic doses = or > 10 mg/day of prednisone or equivalent; Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
- •8. Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
- •9. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
- •10. Rapidly progressive disease (eg, tumor lysis syndrome).
- •11. Gastrointestinal abnormalities including:
- •- Inability to take oral medication;
- •- Requirement for intravenous alimentation;
- •- Prior surgical procedures affecting absorption including total gastric resection;
- •- Treatment for active peptic ulcer disease in the past 6 months;
- •- Active gastrointestinal bleeding, unrelated to cancer, as evidenced by clinically significant hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy;
- •- Malabsorption syndromes;
- •- History of pancreatitis.
- •12. Known prior or suspected hypersensitivity to study drugs or any component in their formulations.
- •13. Active infection requiring systemic therapy.
- •14. Any test for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating acute or chronic infection.
- •15. Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines).
- •16. Any of the following in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes,
Investigators
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