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BRIEF TITLE: 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

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


  • Org Study ID: B9991027
  • Secondary ID: 2017-004345-24,AVE/ AXI COMBO UC,AVE/AXI COMBO UC/NSCLC
  • NCT ID: NCT03472560
  • NCT Alias:
  • Sponsor: Pfizer - Industry
  • Source: Pfizer

Brief Summary

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.

Overal Status Start Date Phase Study Type
Recruiting May 2, 2018 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Confirmed objective response

Primary Outcome 1 - Time Frame: Baseline up to approximately 18 months

Condition:

  • Non-Small Cell Lung Cancer
  • Urothelial Cancer

Eligibility

Criteria:
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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Pfizer CT.gov Call Center

Role: Study Director

Affiliation: Pfizer

Overall Contact

Name: Pfizer CT.gov Call Center

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Link: To obtain contact information for a study center near you, click here.

Locations

Facility Status Contact
Arizona Oncology Associates- Saguaro Cancer Center
Glendale, Arizona 85308
United States
Recruiting
Arizona Oncology Associates- Biltmore Cancer Center
Phoenix, Arizona 85016
United States
Recruiting
Arizona Oncology Associates- Deer Valley Cancer Center
Phoenix, Arizona 85027
United States
Recruiting
Arizona Oncology Associates- East Valley Cancer Center
Tempe, Arizona 85284
United States
Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Not yet recruiting
Karmanos Cancer Institute
Farmington Hills, Michigan 48334
United States
Not yet recruiting
Oncology Hematology Associates
Springfield, Missouri 65807
United States
Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska 68114
United States
Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska 68130
United States
Recruiting
Toledo Clinic Cancer Center- Toledo
Toledo, Ohio 43623
United States
Not yet recruiting
Saint Francis Hospital
Greenville, South Carolina 29601
United States
Recruiting
Saint Francis Hospital Cancer Center
Greenville, South Carolina 29607
United States
Recruiting
Orszagos Onkologiai Intezet
Budapest, H-1122
Hungary
Not yet recruiting
Pecsi Tudomanyegyetem Klinikai Kozpont
Pecs, H-7624
Hungary
Not yet recruiting
Tudogyogyintezet Torokbalint
Torokbalint, H-2045
Hungary
Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do 10408
Korea, Republic of
Recruiting
Samsung Medical Center
Gangnam-gu, Seoul 06351
Korea, Republic of
Recruiting
Asan Medical Center
Songpa-gu, Seoul 05505
Korea, Republic of
Not yet recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic of
Recruiting
Chi Mei Hospital, Liouying
Tainan City, Liouying District 73657
Taiwan
Recruiting
National Cheng Kung University Hospital
Tainan, 704
Taiwan
Not yet recruiting