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

NCT ID: NCT03472560

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-02
• Study Completion Date: 2023-02-09

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.

Conditions

Non-Small Cell Lung Cancer; Urothelial Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Avelumab in combination with axitinib

Avelumab administered at 800 mg IV every two weeks in combination with axitinib, 5 mg PO BID.

Group Type: EXPERIMENTAL

Avelumab (MSB0010718C)

Intervention Type: DRUG

IV treatment: Avelumab administered at 800 mg IV every two weeks

Axitinib (AG-013736)

Intervention Type: DRUG

Oral treatment: Axitinib given 5 mg PO BID

Interventions

Avelumab (MSB0010718C)

IV treatment: Avelumab administered at 800 mg IV every two weeks

Intervention Type: DRUG

Axitinib (AG-013736)

Oral treatment: Axitinib given 5 mg PO BID

Intervention Type: DRUG

Other Intervention Names

Bavencio; Inlyta

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Arizona Oncology Associates- Saguaro Cancer Center

Glendale, Arizona, United States

Arizona Oncology Associates

Goodyear, Arizona, United States

Arizona Oncology Associates- Biltmore Cancer Center

Phoenix, Arizona, United States

Arizona Oncology Associates- Deer Valley Cancer Center

Phoenix, Arizona, United States

Arizona Oncology Associates- East Valley Cancer Center

Tempe, Arizona, United States

The Oncology Institute of Hope and Innovation

Glendale, California, United States

The Oncology Institute of Hope and Innovation

Long Beach, California, United States

The Oncology Institute of Hope and Innovation

Santa Ana, California, United States

The Oncology Institute of Hope and Innovation

Whittier, California, United States

Oncology Hematology Associates

Springfield, Missouri, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, United States

Saint Francis Hospital

Greenville, South Carolina, United States

Saint Francis Hospital Cancer Center

Greenville, South Carolina, United States

Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont

Kecskemét, , Hungary

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, , Hungary

Tudogyogyintezet Torokbalint

Törökbálint, , Hungary

Azienda Ospedaliero Universitaria Policlinico Umberto I

Roma, , Italy

Cardiologia - Azienda Ospedaliero Universitaria Policlinico Umberto I

Roma, , Italy

Farmacia Azienda Ospedaliero Universitaria Policlinico Umberto I

Roma, , Italy

UOC di Radiologia - Azienda Ospedaliero Universitaria Policlinico Umberto I

Roma, , Italy

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie

Warsaw, Masovian Voivodeship, Poland

Regionalny Szpital Specjalistyczny Im. Dr. Wladyslawa Bieganskiego w Grudziadzu

Grudziądz, , Poland

Centrum Medyczne Dom Lekarski S.A.

Szczecin, , Poland

Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie w Warszawie

Warsaw, , Poland

GBUZ of Stavropol Territory "Pyatigorsk Inter-regional Oncology Dispanser"

Pyatigorsk, Stavropol Territory, Russia

LLC "University clinic of headache"

Moscow, , Russia

Limited Liability Company "VitaMed" (LLC "VitaMed")

Moscow, , Russia

LLC "University Clinic of Headache"

Moscow, , Russia

Limited Liability Company "VitaMed" (LLC "VitaMed")

Moscow, , Russia

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Samsung Medical Center

Gangnam-gu, Seoul, South Korea

Asan Medical Center

Songpa-gu, Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Instituto Catalan de Oncologia

L'Hospitalet de Llobregat, Barcelona, Spain

Consorcio Hospitalario Provincial de Castellon

Castellon, Castellon, Spain

Chi Mei Hospital, Liouying

Tainan City, Liouying District, Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

Countries

United States; Hungary; Italy; Poland; Russia; South Korea; Spain; Taiwan

References

Galffy G, Lugowska I, Poddubskaya EV, Cho BC, Ahn MJ, Han JY, Su WC, Hauke RJ, Dyar SH, Lee DH, Serwatowski P, Estelles DL, Holden VR, Kim YJ, Vladimirov V, Horvath Z, Ghose A, Goldman A, di Pietro A, Wang J, Murphy DA, Alhadab A, Laskov M. A phase II open-label trial of avelumab plus axitinib in previously treated non-small-cell lung cancer or treatment-naive, cisplatin-ineligible urothelial cancer. ESMO Open. 2023 Jun;8(3):101173. doi: 10.1016/j.esmoop.2023.101173. Epub 2023 May 2.

Reference Type: DERIVED

PMID: 37141847 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=B9991027

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

Other Identifiers

2017-004345-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AVE/ AXI COMBO UC

Identifier Type: OTHER

Identifier Source: secondary_id

AVE/AXI COMBO UC/NSCLC

Identifier Type: OTHER

Identifier Source: secondary_id

B9991027

Identifier Type: -

Identifier Source: org_study_id