Metastatic Colorectal Cancer Clinical Trial
Official title:
A Phase II/III, Randomized, Open Label, Controlled, Two Arm Study Comparing Overall Survival of AlloStim® Combined With Cryoablation to a Physician's Choice Combined With Cryoablation in 3rd Line Treatment for Metastatic Colorectal Cancer
This is a personalized anti-cancer vaccine protocol which includes an in-situ (in the body) cancer vaccine step which combines killing a single metastatic tumor lesion by use of cryoablation in order to cause the release of tumor-specific markers to the immune system and then injecting bioengineered allogeneic immune cells (AlloStim) into the lesion as an adjuvant in order to modulate the immune response and educate the immune system to kill other tumor cells where ever they reside in the body.
Colorectal cancer (CRC) ranks as the third most common cancer worldwide. Metastasis is the
main reason of death in CRC patients. The current drugs used to treat colorectal cancer
provide important treatment options for patients, their limitations including drug
resistance, poor efficacy and severe side effects. Development of new therapeutic strategies
for KRAS mutant as well as BRAF mutant tumors are therefore highly needed in order to offer a
new category of drug (immunotherapy). This study targets the population of mCRC patients that
have progressed after two lines of chemotherapy and are not eligible for targeted therapies
due to a mutation in KRAS or BRAF.
This is a Phase II/III, randomized, open-label, multicenter, controlled, two arm study
designed to determine the efficacy in terms of OS and the safety of the InSituVax (AlloStim+
Cryoablation) personalized in-situ anti-cancer vaccine protocol (Treatment Arm) compared with
Physician's Choice (PC) of Treatment + Cryoablation (Control Arm) in Metastatic Colorectal
Cancer. Subjects are randomized 2:1 into the treatment or control arms.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01228734 -
A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients
|
Phase 3 | |
| Completed |
NCT05178745 -
A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
|
||
| Completed |
NCT01591421 -
P13Kinase Inhibitor BKM120 in Combination With Panitumumab in Metastatic/Advanced RAS-Wild Type Colorectal Cancer.
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT05412706 -
Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy
|
Phase 2 | |
| Withdrawn |
NCT04430985 -
FOLFOX + Immunotherapy With Intrahepatic Oxaliplatin for Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
| Withdrawn |
NCT03182894 -
Epacadostat in Combination With Pembrolizumab and Azacitidine in Subjects With Metastatic Colorectal Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05725200 -
Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
| Terminated |
NCT03176264 -
PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer
|
Phase 1 | |
| Completed |
NCT04866290 -
HepaSphere™ Microspheres Prospective Registry
|
||
| Not yet recruiting |
NCT06425133 -
Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers
|
Phase 2 | |
| Not yet recruiting |
NCT05531045 -
18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma
|
||
| Withdrawn |
NCT03982173 -
Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors
|
Phase 2 | |
| Completed |
NCT02906059 -
Study of Irinotecan and AZD1775, a Selective Wee 1 Inhibitor, in RAS or BRAF Mutated, Second-line Metastatic Colorectal Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT02575378 -
Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer
|
Phase 4 | |
| Withdrawn |
NCT02535988 -
Abscopal Effect for Metastatic Colorectal Cancer
|
Phase 2 | |
| Recruiting |
NCT02848807 -
Chemotherapy-related Toxicity, Nutritional Status and Quality of Life
|
N/A | |
| Active, not recruiting |
NCT02077868 -
Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment
|
Phase 3 | |
| Completed |
NCT02414009 -
Study to Compare CAPTEM vs FOLFIRI as Second Line Treatment in Advanced, Colorectal Cancer Patients
|
Phase 2 | |
| Active, not recruiting |
NCT01949194 -
Study to Determine the Efficacy of Regorafenib in Metastatic Colorectal Cancer Patients and to Discover Biomarkers
|
Phase 2 | |
| Withdrawn |
NCT01915472 -
A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer
|
Phase 2 |