A Combination of Avelumab and Taxane (AVETAX) for Urothelial Cancer
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|ClinicalTrials.gov Identifier: NCT03575013|
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : April 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Carcinoma||Drug: Avelumab Drug: Docetaxel||Phase 1|
The study is a single institution, phase 1b, single arm non-randomized, open label prospective clinical trial to evaluate the combination of Avelumab and Docetaxel in adult subjects with locally advanced or metastatic urothelial carcinoma with disease progression during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
The study has two phases:
- A Phase 1b dose de-escalation of Docetaxel in combination with Avelumab, to establish the recommended phase 2 dose (RP2D) for the combination. The dose de-escalation phase will utilize a 3+3 design over 3 planned dose levels leading to the identification of a RP2D for the combination of Docetaxel and Avelumab. Note: Dose de-escalation is allowed only for Docetaxel and no changes will done to standard dose of Avelumab (i.e, 10 mg/kg).
- In the dose expansion phase of the study, the fixed dose of Docetaxel in combination with Avelumab will be evaluated. The study is powered to a primary endpoint of overall response rate (ORR) with the combination of Docetaxel and Avelumab. Enrollment for part 2 will commence only after a RP2D is identified from phase 1.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Study of Combination of Avelumab and Taxane Based Chemotherapy in Platinum Refractory or Ineligible Metastatic Urothelial Cancer|
|Actual Study Start Date :||October 29, 2018|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||May 1, 2020|
Experimental: Avelumab and Docetaxel
Avelumab (10 mg/kg) + Docetaxel (75 mg/m2) every 3 weeks for 6 cycles
Avelumab (10 mg/kg) every 2 weeks until disease progression or toxicity
Avelumab is a fully human anti-programmed death ligand 1 (PD-L1) IgG1 antibody
Other Name: MSB0010718C
Docetaxel is a antineoplastic agent belonging to the taxoid family
Other Name: Taxotere
- Dose De-Escalation Phase: To assess dose limiting toxicities (DLTs) using CTCAE v4.03. [ Time Frame: From the start of treatment up to 5 years ]All adverse events (AEs )will be considered in DLT assessment unless an event is clearly unrelated to trial treatment. DLTs for phase 1b only include AEs that are considered possibly, probably, or definitely related to the Docetaxel plus Avelumab regimen which occur during the first 21 days of therapy. All AEs, including DLTs, are to be reported according to instructions in the Study Reference Manual and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.
- Dose Expansion Phase: To determine overall response rate (ORR) (complete response [CR] + partial response [PR]) per RECIST v1.1 [ Time Frame: From the start of treatment up to 5 years ]Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 will be used to determine ORR.
- Dose Expansion: To determine radiologic progression-free survival (PFS) per RECIST v1.1 and immune RECIST criteria [ Time Frame: From the start of treatment up to 5 years ]PFS is defined as the time between the first dose of study therapy and the earliest date of progression or death. Subjects who have neither progressed nor died will be censored at the last tumor assessment date for PFS.
- Dose Expansion: To determine ORR per RECIST v1.1 [ Time Frame: From the start of treatment up to 5 years ]Overall survival defined as the time between the first dose of study therapy and death (subjects who have not died will be censored at the most recent last-known-alive date).
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): NCT03575013
|Contact: Rohan Garje, MDfirstname.lastname@example.org|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Rohan Garje, MD 319-356-1770 email@example.com|
|Principal Investigator:||Rohan Garje, MD||University of Iowa|