Condition or disease | Intervention/treatment | Phase |
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Metastatic Adenoid Cystic Carcinoma Progressive Disease Recurrent Adenoid Cystic Carcinoma | Drug: Avelumab Drug: Axitinib | Phase 2 |
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
EXPLORATORY OBJECTIVES:
I. Assess molecular markers associated with response and resistance to the study combination using tissue and/or plasma obtained from study participants.
OUTLINE:
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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
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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.
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Drug: Avelumab
Given IV
Other Names:
Drug: Axitinib Given PO
Other Names:
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Current use of immunosuppressive medication, EXCEPT for the following:
Contact: Renata Ferrarotto | 713-745-6774 | rferrarotto@mdanderson.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 |
Tracking Information | |||||
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First Submitted Date ICMJE | June 17, 2019 | ||||
First Posted Date ICMJE | June 19, 2019 | ||||
Last Update Posted Date | August 6, 2019 | ||||
Actual Study Start Date ICMJE | July 22, 2019 | ||||
Estimated Primary Completion Date | December 30, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Axitinib and Avelumab in Treating Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma | ||||
Official Title ICMJE | A Phase 2 Clinical Trial of Axitinib and Avelumab in Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma (ACC) | ||||
Brief Summary | This phase II trial studies how well axitinib and avelumab work in treating patients with adenoid cystic carcinoma that has come back or spread to other places in the body. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving axitinib and avelumab together may help to control adenoid cystic carcinoma. | ||||
Detailed Description |
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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. EXPLORATORY OBJECTIVES: I. Assess molecular markers associated with response and resistance to the study combination using tissue and/or plasma obtained from study participants. OUTLINE: 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | 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.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 30, 2022 | ||||
Estimated Primary Completion Date | December 30, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03990571 | ||||
Other Study ID Numbers ICMJE | 2019-0107 NCI-2019-03704 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2019-0107 ( Other Identifier: M D Anderson Cancer Center ) P30CA016672 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | M.D. Anderson Cancer Center | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | ||||
Verification Date | August 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |