Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-27 @ 9:13 PM
Study NCT ID:
NCT03390595
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2017-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Avelumab Plus Carboplatin-gemcitabine in Urothelial Carcinoma
Sponsor:
Associació per a la Recerca Oncologica, Spain
Organization:
Study Overview
Official Title:
Phase II Multicentre, Randomized, Open-label Study to Evaluate the Safety and Efficacy of Avelumab With Gemcitabine/Carboplatin Versus Gemcitabine/Carboplatin Alone in Patients With Unresectable or Metastatic Urothelial Carcinoma (UC) Who Have Not Received Prior Systemic Therapy and Who Are Ineligible to Receive Cisplatin-based Therapy.
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INDUCOMAIN
Brief Summary:
Phase II Multicentre, randomized, open-label study to evaluate the safety and efficacy of avelumab with gemcitabine/carboplatin versus gemcitabine/carboplatin alone in patients with unresectable or metastatic urothelial carcinoma (UC) who have not received prior systemic therapy and who are ineligible to receive cisplatin-based therapy.
Detailed Description:
The aim of this study is to evaluate if the response rates (complete response \[CR\] + partial response \[PR\]) are sufficiently high and the severe acute toxicity rates acceptably low. Patients must be cisplatin-ineligible as defined by consensus criteria (see Inclusion criteria). Patients who experience disease progression \>12 months following completion of a platinum-based adjuvant or neoadjuvant regimen will also be eligible for enrolment into the study.
Once it is confirmed that the subjects fulfil the eligibility criteria and have signed the informed consent form, they will be randomized in a 1:1 ratio to receive avelumab in combination with gemcitabine/carboplatin or gemcitabine/carboplatin alone as follows:
* Arm A: patients will receive 2 cycles of induction avelumab 10mg/kg every 2 weeks followed by 6 cycles of carboplatin/gemcitabine plus avelumab (carboplatin 5AUC day +1, gemcitabine 1000mg/m2 day +1 and +8 and avelumab 10mg/kg day +15) every 3 weeks followed by avelumab monotherapy 10mg/kg every 2 weeks until progressive disease or intolerance.
* Arm B: patients will receive 6 cycles of carboplatin/gemcitabine (carboplatin 5AUC day +1, gemcitabine 1000mg/m2 day +1 and +8) every 3 weeks.
Random assignment of treatment will be stratified by the presence or absence of visceral metastasis and ECOG \< 2 versus ECOG 2.
All the patients enrolled in avelumab arm will receive avelumab monotherapy maintenance until disease progression or intolerable/unacceptable toxicity. Patients in the carboplatin-gemcitabine arm, will receive up to six cycles of treatment. Tumour evaluations will be scheduled every 6 weeks (±2 weeks) during carboplatin-gemcitabine treatment (in case of cycle delay this tumour evaluations every 6 weeks should be maintained to avoid any bias in the assessment of date of progression with appropriate imaging studies for response evaluation) and every 9 weeks thereafter until progressive disease (during this period, patients at arm A will be receiving avelumab maintenance treatment).
Patients with disease progression during the treatment phase will be withdrawn from the study and will receive their treatment according to the investigator's judgment and monitored to evaluate OS.
If a patient withdraws consent and refuses to receive more treatment, the patient must be followed up for survival. If a patient withdraws consent and refuses to continue in the study, the follow-up evaluations must be discontinued.
If at the moment of end of study there would be any patient still on maintenance treatment with avelumab, Sponsor will have commitment to provide the study drug in case patient is having clinical benefit.
Once it is confirmed that the subjects fulfil the eligibility criteria and have signed the informed consent form, they will be randomized in a 1:1 ratio to receive avelumab in combination with gemcitabine/carboplatin or gemcitabine/carboplatin alone as follows:
* Arm A: patients will receive 2 cycles of induction avelumab 10mg/kg every 2 weeks followed by 6 cycles of carboplatin/gemcitabine plus avelumab (carboplatin 5AUC day +1, gemcitabine 1000mg/m2 day +1 and +8 and avelumab 10mg/kg day +15) every 3 weeks followed by avelumab monotherapy 10mg/kg every 2 weeks until progressive disease or intolerance.
* Arm B: patients will receive 6 cycles of carboplatin/gemcitabine (carboplatin 5AUC day +1, gemcitabine 1000mg/m2 day +1 and +8) every 3 weeks.
Random assignment of treatment will be stratified by the presence or absence of visceral metastasis and ECOG \< 2 versus ECOG 2.
All the patients enrolled in avelumab arm will receive avelumab monotherapy maintenance until disease progression or intolerable/unacceptable toxicity. Patients in the carboplatin-gemcitabine arm, will receive up to six cycles of treatment. Tumour evaluations will be scheduled every 6 weeks (±2 weeks) during carboplatin-gemcitabine treatment (in case of cycle delay this tumour evaluations every 6 weeks should be maintained to avoid any bias in the assessment of date of progression with appropriate imaging studies for response evaluation) and every 9 weeks thereafter until progressive disease (during this period, patients at arm A will be receiving avelumab maintenance treatment).
Patients with disease progression during the treatment phase will be withdrawn from the study and will receive their treatment according to the investigator's judgment and monitored to evaluate OS.
If a patient withdraws consent and refuses to receive more treatment, the patient must be followed up for survival. If a patient withdraws consent and refuses to continue in the study, the follow-up evaluations must be discontinued.
If at the moment of end of study there would be any patient still on maintenance treatment with avelumab, Sponsor will have commitment to provide the study drug in case patient is having clinical benefit.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-004260-36 | EUDRACT_NUMBER | None | View |