Study Comparing AlloVax™ to Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head & Neck
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|ClinicalTrials.gov Identifier: NCT02624999|
Recruitment Status : Unknown
Verified July 2016 by Immunovative Therapies, Ltd..
Recruitment status was: Not yet recruiting
First Posted : December 9, 2015
Last Update Posted : July 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma Head and Neck||Biological: AlloVax™ Drug: Cisplatin||Phase 2|
All accrued subjects will be randomized 2:1 to AlloVax™ (CRCL + AlloStim™) immunotherapy vs. standard chemotherapy. AlloVax™ is an experimental individualized therapeutic vaccine shown to be active in this study population.
The standard chemotherapy arm (Arm 1) will receive up to six three-week cycles of chemotherapy consisting of cisplatin on day 0 of the 3-week cycle at dose 80-100 mg/m2 IV followed by 1000 mg/m2 IV flurouracil (5FU) on days 1-4 of the cycle.
The immunotherapy arm (Arm 2) will receive immunotherapy (AlloVax™) twice a week for 4 weeks and then every 4 weeks for an additional 12 weeks.
The study is designed and powered to determine if AlloVax™ is not inferior to the active chemotherapy control.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Individualized Cancer Vaccine for Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (SCCHN)|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||May 2019|
Subjects in this arm will receive immunotherapy (AlloVax™: CRCL + AlloStim™) twice a week for 4 weeks and then every 4 weeks for an additional 12 weeks
AlloVax™ combines an anti-tumor effect of mini-transplant procedures with patient specific tumor antigens
Other Name: CRCL + AlloStim™
Active Comparator: Standard chemotherapy
Subjects in this arm will receive up to six three-week cycles of chemotherapy consisting of cisplatin on day 0 of the 3-week cycle at dose 80-100 mg/m2 IV followed by 1000 mg/m2 IV 5FU on days 1-4 of the cycle
Subjects in the chemotherapy arm will receive up to 6 cycles of cisplatin on day 0 of the 3-week cycle at dose of 80-100 mg/m2 IV and 1000 mg/m2 IV 5FU on days 1-4 of the cycle
Other Name: Standard Chemotherapy
- Safety and tolerability (vital signs, physical examination, clinical laboratory profile, adverse events assessed by CTCAE v4.0 and dose limiting toxicity (DLT)) [ Time Frame: 119 days ]Whether AlloVax™ is less toxic than chemotherapy. will be evaluated on the basis of the following parameters: vital signs, physical examination, clinical laboratory profile, adverse events assessed by CTCAE v4.0 and dose limiting toxicity (DLT)
- Overall Survival [ Time Frame: 119 days ]Whether AlloVax™ is not inferior to the active chemotherapy control (from time of randomization). Subjects are followed for survival during the trial and as long as they are alive after the last study treatment through follow-up
- Health related Quality of Life (HRQoL) [ Time Frame: 119 days ]QLQ-C30 and QLQ-H&N35 questionnaires
- RECIST [ Time Frame: 119 days ]Response and correlation with pathology assessment
- Immune-Related Response Criteria (irRC) [ Time Frame: 119 days ]Response and correlation with pathology assessment
- Immune response in the treatment arm [ Time Frame: 119 days ]Correlation of OS with immune response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624999
|Contact: Chindavijak Somjin, MD||+66 89 email@example.com|
|Contact: Nitiya Ritthidechratn||+662 619 13356||nitiya@Immunovative.com|
|National Cancer Institute of Thailand||Not yet recruiting|
|Bangkok, Thailand, 10400|
|Contact: Chindavijak Somjin, MD +66 89 6937679 firstname.lastname@example.org|
|Contact: Nitiya Ritthidechratn +66261913356 email@example.com|
|Principal Investigator: Chindavijak Somjin, MD|
|Study Director:||Michael Har-Noy, Dr.||CEO & CTO|