Renal Cell Carcinoma Clinical Trial
Official title:
Phase 2, Randomized, Open Label, Multicenter Study of Intradermal IMA901 Plus GM-CSF With or Without Low Dose Cyclophosphamide Pre-treatment in Advanced Renal Cell Carcinoma Patients With Measurable Disease
This study was conducted in order to evaluate the efficacy and safety of the cancer vaccine
IMA901 and GM-CSF as adjuvant in the treatment of advanced renal cell carcinoma.
Patients received vaccination with GM-CSF followed by IMA901 during the study period of 9
months. Patients received pre-treatment with a single i.v. infusion of cyclophosphamide
prior to the first vaccination.
This is a multicenter, open label, randomized phase 2 study which investigated the effect of
a second-line systemic treatment with IMA901 plus GM-CSF in RCC patients. Randomization was
done according to a pre-treatment with low-dose cyclophosphamide (CY). Secondary endpoints
comprised tumor response parameters.
The study population consisted of HLA-A*02-positive men or women with advanced RCC of the
clear-cell type classified as having a favorable or intermediate risk after first-line
systemic therapy for. Patients had to be aged 18 years or older, had at least have one
measurable tumor lesion and had have received first-line tyrosine kinase inhibitor or
cytokine systemic therapy for advanced disease, during or after which the patient had
experienced disease progression.
Patients in both arms received a total of 17 vaccinations with GM-CSF followed by IMA901
during the 9 month treatment period.
At screening baseline tumor status was assessed by CT or MRI. During the study tumor
assessments were performed every 6 weeks.
Immunomonitoring (T-cell responses to peptides contained in IMA901 and analysis of other
immune cell populations that may influence T-cell responses), serum levels of antibodies and
molecules with suspected influence on immune response were assessed on several occasions
during the study.
Safety assessment comprised continuous adverse event reporting, regular physical
examinations and regular assessments of vital signs, hematology, blood chemistry and urine.
A 12-lead ECG was performed at screening and at the end of the study. Pregnancy testing was
performed according to applicable legislation in the country where the trial was performed.
At the very least, women of childbearing potential had have to undergo a pregnancy test
during screening for the study, before the first dose was applied and at the end of the
study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04987203 -
Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma
|
Phase 3 | |
Recruiting |
NCT06391879 -
Establishment of a Multidimensional Prediction Model for the Natural Course of VHL Disease-related Renal Cell Carcinoma
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
Terminated |
NCT03655613 -
APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05418387 -
A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona
|
N/A | |
Recruiting |
NCT04623502 -
An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy
|
N/A | |
Completed |
NCT02853344 -
Study of Pembrolizumab (MK-3475) Monotherapy in Locally Advanced/Metastatic Renal Cell Carcinoma (MK-3475-427/KEYNOTE-427)
|
Phase 2 | |
Terminated |
NCT04088500 -
A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma
|
Phase 2 | |
Completed |
NCT05070637 -
Circulating Tumor Cell Reducing No-touch Nephrectomy
|
N/A | |
Active, not recruiting |
NCT03634540 -
A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)
|
Phase 2 | |
Not yet recruiting |
NCT06049030 -
A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma
|
Phase 1 | |
Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
Completed |
NCT01358721 -
Phase I Biomarker Study (BMS-936558)
|
Phase 1 | |
Active, not recruiting |
NCT04503148 -
Anesthesia and Cancer Study: Renal Cell Carcinoma
|
N/A | |
Completed |
NCT02386826 -
INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme
|
Phase 1 | |
Not yet recruiting |
NCT05808608 -
A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma
|
Phase 1/Phase 2 | |
Withdrawn |
NCT03323710 -
Study of Propranolol Plus Sunitinib in First-line Treatment of Metastatic Renal Cell Carcinoma
|
Phase 2 | |
Not yet recruiting |
NCT02787915 -
DC1s-CTL Cellular Therapy for Renal Cell Carcinoma
|
Phase 1/Phase 2 |