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Clinical Trial VICCMD1636

Title

A Phase 1b/2 Open-Label Study to Evaluate Safety, Clinical Activity, Pharmacokinetics and Pharmacodynamics of Avelumab (MSB0010718C) in Combination with Other Cancer Immunotherapies in Patients with Advanced Malignancies

Principal Investigator(s)

Douglas Johnson

Details

  • Protocol No. VICCMD1636
  • Open Date: 12/21/2016
  • Staging: Phase I/II
  • Age Group: Adults
  • Scope: National
  • Objective: Phase 1b lead-in: To assess safety and tolerability of avelumab in combination with increasing dose levels of other immune modulators in combination with a single dose level of avelumab in patients with advanced solid tumors in order to select the Recommended Phase 2 Dose(s) (RP2D)/schedule for the combination. Phase 2: To assess objective response (OR) of avelumab in combination with other immune modulators in patients with locally advanced or metastatic cancer [ie, non-small cell lung cancer (NSCLC), melanoma, or squamous cell carcinoma of the head and neck (SCCHN)].
  • Disease Sites: Head/Neck; Melanoma; Lung; Non Small Cell
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Avelumab; PD 0360324; PF-04518600; PF-05082566(Utomilumab); PF-06840003
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02554812
  • Secondary Protocol No: B9991004

Description

None Provided.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:All
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Histological or cytological diagnosis of advanced/metastatic solid tumor. Combination A: Phase 1b, patients with NSCLC that have progressed on standard therapy or for which no standard therapy is available, and Phase 2, patients with NSCLC, melanoma, SCCHN, TNBC in any line of therapy, SCLC, 1st line NSCLC. Combination B: Phase 1b, patients with advanced solid tumors that have progressed on standard therapy or for which no standard therapy is available, and Phase 2, patients with NSCLC, melanoma, or SCCHN in any line of therapy, or locally advanced/metastatic CRC progressed after 1 line of standard therapy. NSCLC patients in Phase 2 with tumor ALK or EGFR mutations must have received or been refractory/intolerant to standard therapy. Combination C: Ovarian cancer, SCCHN, NSCLC, or gastric cancer, that has progressed after at least 1 line of standard therapy or is ineligible for/intolerant to SOC. Combination D: NSCLC, melanoma, or SCCHN that has progressed after at least 1 line of standard therapy or is ineligible for/intolerant to SOC.
• ECOG performance status 0 or 1
• Estimated life expectancy of at least 3 months
• Adequate bone marrow, renal, and liver function
• Resolved acute effects of prior therapy
• Negative serum pregnancy test at screening
• Male and female patients able to have children must agree to use 2 highly effective methods of contraception throughout the study and for at least 60 days after last dose
• Signed and dated informed consent
Exclusion Criteria:
• Monoclonal antibody based anti-cancer therapy within 28 days prior to study entry or small-molecule based anti-cancer therapy (targeted therapy or chemotherapy) within 14 days prior to study entry.
• Current or prior use of immunosuppressive medication within 7 days prior to study entry
• Active autoimmune disease requiring systemic steroids or immunosuppressive agents within 7 days prior to study entry
• Known prior or suspected hypersensitivity to investigational products
• Major surgery within 4 weeks or radiation therapy within 14 days prior to study entry
• Patients with known symptomatic brain metastases requiring steroids
• Previous high-dose chemotherapy requiring stem cell rescue
• Prior allogeneic stem cell transplant or organ graft
• Any of the following within 6 months prior to study entry: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack
• Symptomatic pulmonary embolism within 6 months prior to study entry
• Known HIV or AIDS-related illness
• Active infection requiring systemic therapy
• Positive HBV or HCV test indicating acute or chronic infection
• Administration of a live vaccine within 4 weeks prior to study entry
• Diagnosis of other malignancy within 5 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix, or low-grade (Gleason ≤6) prostate cancer
• Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry and/or during study participation
• Persisting toxicity related to prior therapy >Grade 1
• Other severe acute or chronic medical condition