Axitinib and Avelumab in Treating Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma
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|ClinicalTrials.gov Identifier: NCT03990571|
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : August 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Adenoid Cystic Carcinoma Progressive Disease Recurrent Adenoid Cystic Carcinoma||Drug: Avelumab Drug: Axitinib||Phase 2|
I. Assess the objective response rate (ORR) to axitinib and avelumab combination according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria patients with recurrent or metastatic adenoid cystic carcinoma (ACC) who have evidence of disease progression within 6 months prior to study enrollment.
I. Assess ORR to axitinib and avelumab combination according to immune-related (ir)RECIST criteria patients with recurrent or metastatic adenoid cystic carcinoma (ACC).
II. Evaluate median progression free survival (PFS), PFS rate at 6 months after start of treatment.
III. Evaluate median overall survival (OS), OS rate at 6 months after start of treatment.
IV. Evaluate duration of response (DoR). V. Evaluate safety and toxicity.
I. Assess molecular markers associated with response and resistance to the study combination using tissue and/or plasma obtained from study participants.
Patients receive axitinib orally (PO) twice daily (BID) on days 1-28 and avelumab intravenously (IV) over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 and 90 days and then every 6 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Clinical Trial of Axitinib and Avelumab in Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma (ACC)|
|Actual Study Start Date :||July 22, 2019|
|Estimated Primary Completion Date :||December 30, 2022|
|Estimated Study Completion Date :||December 30, 2022|
Experimental: Treatment (axitinib, avelumab)
Patients receive axitinib PO BID on days 1-28 and avelumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
- Overall response rate [ Time Frame: Up to 6 months ]Will be evaluated per Response Evaluation Criteria in Solid Tumors 1.1 criteria. The trial will be conducted by Simon's 2-stage design and the response rate will be estimated after the second stage. The response rate will be estimated along with its 95% confidence interval.
- Overall survival [ Time Frame: At 6 months after start of treatment ]Will be estimated using the method of Kaplan and Meier.
- Progression-free survival [ Time Frame: At 6 months after start of treatment ]Will be estimated using the method of Kaplan and Meier.
- Duration of response [ Time Frame: Up to 3 years ]Will be estimated using the method of Kaplan and Meier.
- Incidence of adverse events [ Time Frame: Up to 4 weeks after start of study treatment ]Toxicity is defined as adverse events in the first 4 weeks that are judged to be attributable to one agent or both in combination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990571
|Contact: Renata Ferrarottofirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Renata Ferrarotto 713-792-6363|
|Principal Investigator: Renata Ferrarotto|
|Principal Investigator:||Renata Ferrarotto||M.D. Anderson Cancer Center|