Ignite Creation Date:
2024-05-06 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05096390
Status:
RECRUITING
Last Update Posted:
2024-01-25
First Post:
2021-10-14
Brief Title:
Axitinib - Pembrolizumab in First Line Treatment of mPRCC
Sponsor:
Centre Leon Berard
Organization:
Centre Leon Berard
Study Overview
Official Title:
Multicenter Phase II Study of Axitinib - Pembrolizumab in First Line Treatment for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma PRCC
Status:
RECRUITING
Status Verified Date:
2024-01
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:
PAXIPEM
Brief Summary:
Multicenter Phase II Study of Axitinib - Pembrolizumab in First Line Treatment for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma PRCC
Detailed Description:
Papillary renal cell carcinoma PRCC is the second most common subtype of renal carcinoma accounting for approximatively 10-15 of all renal cancers Different types of PRCC have been described on the basis of two histologic subtypes type 1 in 25 to 30 cases and type 2 with a worse prognosis reported for type 2 metastatic disease There is currently no standard of care specifically dedicated to metastatic PRCC patients mPRCC and treatments developed for metastatic clear cell carcinomas are commonly used therefore mPRCC enrollment in clinical trials is encouraged
Clinical trials investigated treatments such as sunitinib or everolimus approved for advanced clear cell carcinoma or the dual kinase inhibitor directed both towards VEGF receptors VEGFr and the MET pathway foretinib or more recently the selective MET inhibitor savolitinib Response rates RR were disappointing since generally below 15 except in a subset of patients with MET germline alterations
Axitinib which is indicated as second-line treatment in advanced clear cell carcinoma was investigated in a recent specific trial the Axipap trial This multicentric phase II trial was conducted after central pathology review to confirm the histologic subtype and a central review was performed to assess the primary endpoint the 24 week progression free rate 24wPFR With a median follow up time of 30 months this 24wPFR was found to be over 45 The best response rate was 286 according to the investigators with a median duration of response near 8 months The investigator assessed response rate was 357 in the type 2 subgroup indicating a more important effect of anti-VEGFr in this subtype than in the type 1 The median PFS was around 6 months and was virtually identical in both subtypes
Recently some preliminary results of the use of Immune Checkpoint Inhibitors in metastatic non clear cell carcinoma were made available The PD1 directed antibody Pembrolizumab showed a 28 response rate in 118 patients with papillary tumors including a 6 complete remission rate the median duration of response was of 153 28-210 months Atezolizumb anti-PDL1 combined with Bevacizumab and Durvalumab anti-PDL1 combined with savolitinib Met directed TKI obtained response rates in the same range These preliminary results demonstrated the potential interest of combining axitinib with an immune check point inhibitor The results of pembrolizumab as monotherapy were obtained in the largest subset with mPRC
According to these results obtained the combination of axitinib and pembrolizumab seems promising in type 2 papillary tumors
Clinical trials investigated treatments such as sunitinib or everolimus approved for advanced clear cell carcinoma or the dual kinase inhibitor directed both towards VEGF receptors VEGFr and the MET pathway foretinib or more recently the selective MET inhibitor savolitinib Response rates RR were disappointing since generally below 15 except in a subset of patients with MET germline alterations
Axitinib which is indicated as second-line treatment in advanced clear cell carcinoma was investigated in a recent specific trial the Axipap trial This multicentric phase II trial was conducted after central pathology review to confirm the histologic subtype and a central review was performed to assess the primary endpoint the 24 week progression free rate 24wPFR With a median follow up time of 30 months this 24wPFR was found to be over 45 The best response rate was 286 according to the investigators with a median duration of response near 8 months The investigator assessed response rate was 357 in the type 2 subgroup indicating a more important effect of anti-VEGFr in this subtype than in the type 1 The median PFS was around 6 months and was virtually identical in both subtypes
Recently some preliminary results of the use of Immune Checkpoint Inhibitors in metastatic non clear cell carcinoma were made available The PD1 directed antibody Pembrolizumab showed a 28 response rate in 118 patients with papillary tumors including a 6 complete remission rate the median duration of response was of 153 28-210 months Atezolizumb anti-PDL1 combined with Bevacizumab and Durvalumab anti-PDL1 combined with savolitinib Met directed TKI obtained response rates in the same range These preliminary results demonstrated the potential interest of combining axitinib with an immune check point inhibitor The results of pembrolizumab as monotherapy were obtained in the largest subset with mPRC
According to these results obtained the combination of axitinib and pembrolizumab seems promising in type 2 papillary tumors
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ET21-023 | OTHER | Centre Leon Berard | None |