A Study of Avelumab in Combination With Axitinib In Non-Small Cell Lung Cancer (NSCLC) or Urothelial Cancer (Javelin Medley VEGF)



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Prostate Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:May 2, 2018
End Date:September 18, 2020
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A PHASE 2, OPEN LABEL STUDY TO EVALUATE SAFETY AND CLINICAL ACTIVITY OF AVELUMAB (BAVENCIO (REGISTERED)) IN COMBINATION WITH AXITINIB (INLYTA (REGISTERED)) IN PATIENTS WITH ADVANCED OR METASTATIC PREVIOUSLY TREATED NON-SMALL CELL LUNG CANCER OR TREATMENT NAÏVE CISPLATIN-INELIGIBLE UROTHELIAL CANCER JAVELIN MEDLEY VEGF

This is a Phase 2 study to evaluate the safety and efficacy of avelumab in combination with
axitinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have
received at least one prior platinum containing therapy, and in treatment naïve patients with
advanced or metastatic urothelial cancer, who are ineligible for cisplatin containing
chemotherapy for their advanced disease.


Inclusion Criteria:

- Non-small cell lung cancer (NSCLC) Cohort: Histologically or cytologically confirmed
diagnosis of NSCLC that is locally advanced or metastatic; No activating EGFR
mutations, ALK or ROS1 translocations/rearrangements where testing is standard of
care; received at least 1 prior platinum‑based chemotherapy regimen for locally
advanced or metastatic NSCLC; No more than 2 prior lines of systemic therapy for
locally advanced or metastatic disease (If disease progression occurred during or
within 6 months after neoadjuvant/adjuvant chemotherapy or radiotherapy‑chemotherapy,
the regimen is counted as 1 prior treatment regimen towards the allowed limit of prior
treatment regimens); Checkpoint inhibitor naïve.

- Urothelial Cancer (UC) Cohort: Histologically or cytologically confirmed diagnosis of
transitional cell carcinoma (TCC) of the urothelium (if mixed, more than 50% TCC
component) including bladder, urethra, ureters, or renal pelvis that is locally
advanced or metastatic; No prior systemic treatment for locally advanced or metastatic
disease; Prior neoadjuvant or adjuvant therapy is permitted if disease progression
occurred >12 months after the completion of therapy; Checkpoint inhibitor naïve;
Ineligible for receiving cisplatin‑containing front‑line chemotherapy based at least
one of the following criteria: ECOG performance status (PS) 2; Renal dysfunction
(defined as creatinine‑clearance <60 ml/min); Grade 2 peripheral neuropathy; Grade 2
hearing loss (hearing loss measured by audiometry of 25 decibels at two contiguous
frequencies).

- At least 1 measurable lesion by RECIST v1.1 not previously irradiated.

- Availability of an archival FFPE tumor tissue block from primary diagnosis specimen or
metastatic specimen or 15 unstained slides (10 minimum). If an archived sample is not
available, a fresh tumor biopsy must be performed.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. For UC
patients, ECOG performance 2 is permitted (cisplatin ineligibility criterion)

Exclusion Criteria:

- Prior immunotherapy with an anti‑PD‑1, anti‑PD‑L1, anti‑PD‑L2, anti‑CD137, anti‑OX‑40,
anti‑GITR, anti‑LAG‑3, anti‑TIM‑3 or anti‑CTLA‑4 antibody (including ipilimumab).

- Newly diagnosed brain metastases or known symptomatic brain metastases requiring
steroids.

- Radiologically documented evidence of major blood vessel invasion or encasement by
cancer or intratumor cavitation, regardless of tumor histology.

- Active autoimmune disease (that might deteriorate when receiving an immunostimulatory
agent).

- Current use of immunosuppressive medication (except for those listed in protocol).

- Known prior severe hypersensitivity to the investigational products /monoclonal
antibodies.

- Known history of immune‑mediated colitis, inflammatory bowel disease, immune‑mediated
pneumonitis, pulmonary fibrosis.

- NCI CTCAE Grade 3 hemorrhage within 28 days prior to study enrollment.
We found this trial at
20
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Detroit, Michigan 48201
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Farmington Hills, Michigan 48334
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1510 South Central Avenue
Glendale, California 91204
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1 St. Francis Drive
Greenville, South Carolina 29601
864-255-1000
Saint Francis Hospital This 245-bed, all-private-room facility is located near downtown Greenville, South Carolina. Formerly...
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Greenville, South Carolina
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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New York, New York 10029
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New York, New York 10029
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Santa Ana, California 92705
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Springfield, Missouri 65807
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15111 Whittier Boulevard
Whittier, California 90603
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