Metastatic Renal Cell Carcinoma Clinical Trial
Official title:
A Randomized, Controlled Phase III Study Investigating IMA901 Multipeptide Cancer Vaccine in Patients Receiving Sunitinib as First-line Therapy for Advanced/Metastatic Renal Cell Carcinoma
The primary objective of the phase III study is to investigate whether IMA901 can prolong
overall survival in patients with metastatic and/or locally advanced renal cell carcinoma
(RCC) when added to standard first-line therapy with sunitinib.
Secondary objectives include a subgroup analysis of overall survival in patients defined by a
certain biomarker signature, the investigation of progression-free survival, best tumor
response, safety, and immunological parameters.
This is a multicenter, open-label, randomized phase III study to investigate whether
therapeutic vaccination with IMA901, a mult-peptide cancer vaccine (TUMAP), can prolong
overall survival in patients with metastatic and/or locally advanced RCC when added to
standard first-line therapy with sunitinib (primary endpoint).
Secondary endpoints include a subgroup analysis of overall survival in patients who are
positive for a prospectively defined primary biomarker signature (identified as being
predictive for improved clinical outcome in IMA901-vaccinated patients in the previous phase
II study), progression-free survival (PFS), best overall response, cellular immunomonitoring
in a subset of patients, and safety. Safety analysis will be based on adverse events (AEs),
physical examinations, vital signs, hematology, clinical chemistry, urinalysis and ECG
changes.
Further endpoints include subgroup analyses of overall survival in patients who are positive
for further prospectively defined biomarkers (identified in the previous phase II study), and
exploratory screening of new biomarkers (to be investigated in patients' blood and paraffin
sections from tumor tissue) to predict better clinical outcome as response to vaccination
with IMA901. Biomarker sets will not be used for patient selection in this study.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00930033 -
Clinical Trial to Assess the Importance of Nephrectomy
|
Phase 3 | |
| Recruiting |
NCT05863351 -
Focused Radiation Versus Systemic Therapy for Kidney Cancer Patients With Limited Metastasis, SOAR Study
|
Phase 3 | |
| Not yet recruiting |
NCT06284564 -
A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC)
|
Phase 2 | |
| Completed |
NCT00414765 -
Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma
|
Phase 4 | |
| Active, not recruiting |
NCT03149822 -
Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03647878 -
Study of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment.
|
||
| Completed |
NCT01517243 -
Phase II Study of Alternating Sunitinib and Temsirolimus
|
Phase 2 | |
| Withdrawn |
NCT03927248 -
PAC-1 for Treatment of Refractory, Metastatic Kidney Cancer
|
Phase 1/Phase 2 | |
| Terminated |
NCT02122003 -
Second Line Sorafenib After Pazopanib in Patients With RCC
|
Phase 2 | |
| Completed |
NCT01182142 -
Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma (RCC) Patients
|
Phase 2 | |
| Completed |
NCT00630409 -
Phase II Clinical Trial of Gemcitabine and Doxil® for Metastatic Renal Cell Carcinoma
|
Phase 2 | |
| Recruiting |
NCT04140526 -
Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
|
Phase 1/Phase 2 | |
| Completed |
NCT04076787 -
Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib
|
||
| Active, not recruiting |
NCT04467021 -
Cancer and Blood Pressure Management, CARISMA Study
|
N/A | |
| Recruiting |
NCT05119335 -
A Study of NKT2152, a HIF2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma
|
Phase 1/Phase 2 | |
| Completed |
NCT02282579 -
Spanish Retrospective Study to Evaluate the Efficacy and Safety of Targeted Therapies After Pazopanib as First-line Therapy
|
||
| Completed |
NCT01731158 -
Sequential Therapy in Metastatic Renal Cell Carinoma
|
Phase 2 | |
| Terminated |
NCT02071641 -
Phase II Study of Sunitinib Rechallenge in Patients With Metastatic Renal Cell Carcinoma
|
Phase 2 | |
| Terminated |
NCT01342627 -
Sorafenib in Elderly Patients With Metastatic Renal Cell Carcinoma
|
Phase 2 | |
| Active, not recruiting |
NCT01274273 -
Study of Interleukin-2, Interferon-alpha and Bevacizumab in Metastatic Kidney Cancer
|
Phase 2 |