Ignite Creation Date:
2024-05-06 @ 9:18 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02955290
Status:
RECRUITING
Last Update Posted:
2023-11-08
First Post:
2016-11-02
Brief Title:
CIMAvax Vaccine Nivolumab and Pembrolizumab in Treating Patients With Advanced Non-small Cell Lung Cancer or Squamous Head and Neck Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase III Basket Trial of the EGF Vaccine CIMAvax in Combination With Anti-PD1 Therapy in Patients With Advanced NSCLC or Squamous Head and Neck Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
This phase III trial studies the best dose and side effects of recombinant human EGF-rP64Kmontanide ISA 51 vaccine CIMAvax and nivolumab and to see how well they work in treating patients with non-small cell lung cancer or squamous head and neck cancer that has spread to other places in the body Vaccine therapy such as CIMAvax vaccine may help slow down and stop tumor growth Immunotherapy with monoclonal antibodies such as nivolumab and pembrolizumab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Giving CIMAvax vaccine together with nivolumab or pembrolizumab may work better in treating patients with non-small cell lung cancer or squamous head and neck cancer
Detailed Description:
PRIMARY OBJECTIVES
I To identify the maximum dose of CIMAvax in combination with nivolumab based on dose limiting toxicities DLTs as assessed by Common Terminology Criteria for Adverse Events version 403 CTCAE version v 403 Phase I
II To evaluate the 12-month overall survival of CIMAvax combined with nivolumab in patients with advanced non-small cell lung cancer NSCLC Phase II-Study A
III To evaluate the 6-month progression free survival PFS of CIMAvax combined with nivolumab in patients with advanced recurrent squamous cell carcinoma of the head and neck Phase II-Study B
IV To evaluate the objective response rate of pembrolizumab in combination with CIMAvax as first-line therapy in patients with advanced NSCLC PD-L1 expression 50 Phase II-Study C
V To evaluate the 12-month PFS of pembrolizumab in combination with CIMAvax as maintenance therapy in patients with advanced squamous NSCLC PD-L1 expression 50 Phase II-Study D
VI To evaluate the 12-month PFS of pembrolizumab in combination with CIMAvax as maintenance therapy in patients with advanced NON-squamous NSCLC without EGFRALKROS-1KRAS mutations PD-L1 expression 50 Phase II- Study E
SECONDARY OBJECTIVES
I To assess the toxicity of CIMAvax combined with nivolumab using the Cancer Therapy Evaluation Program CTEP National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE version 403 Phase I
II Determine the preliminary efficacy of the combination of anti-PD1 therapy with CIMAvax Phase I III To evaluate progression free survival PFS for the combination of CIMAvax and nivolumab in patients with advanced NSCLC Phase II-Study A IV To evaluate the 12-month overall survival of patients with advanced recurrent squamous cell carcinoma of the head and neck who received nivolumab in combination with CIMAvax Phase II-Study B
V To evaluate the PFS and 12-month overall survival of CIMAvax in combination with pembrolizumab as first-line therapy in patients with advanced NSCLC PD-L1 expression 50 Phase II-Study C
VI To evaluate the PFS and overall survival of CIMAvax in combination with pembrolizumab as maintenance therapy in patients with advanced squamous NSCLC PD-L1 expression 50 Phase iI- Study D
VII To evaluate the PFS and overall survival of CIMAvax in combination with pembrolizumab as maintenance treatment in non-squamous NSCLC patients without EGFRALKROS-1KRAS mutations after induction chemoimmunotherapy PD-L1 expression 50Phase II - Study E
VIII To assess the toxicity of CIMAvax combined with nivlumab or pembrolizumab suing the CTEP NCI Common Terminology Criteria for Adverse Events CTCAE version 403 Phase II
TERTIARY OBJECTIVES
I To conduct correlative studies comparing blood EGF levels platelet levels markers of immune response and functionality of antibody response Phase I II To examine the association of EGFR total and activated PD-1 and PD-L1 expression and mutations in tumor tissue with biomarkers of genetic and immune response Phase I and II III Comparison of response assessment criteria for a prospective analysis immune-related ir Response Evaluation Criteria in Solid Tumors RECIST response assessment versus vs immune-related Response Criteria irRC vs RECIST 11 Phase I and II IV To characterize the blood EGF levels and other blood-based biomarkers of patients censored from the trial because of low titer response Phase II
OUTLINE This is a phase I dose escalation study of CIMAvax followed by a phase II study
LOADING PHASE I Patients receive CIMAvax intramuscularly IM and nivolumab intravenously IV over 60 minutes on day 1 Treatment repeats every 2 weeks for up to 4 doses in the absence of disease progression or unacceptable toxicity Within 4 weeks after the 4th dose patients receive CIMAvax IM at the same time as the next nivolumab dose
MAINTENANCE PHASE I Patients who do not experience a DLT receive CIMAvax every 4 weeks and nivolumab every 2 weeks
PHASE II STUDY A and B Patients receive CIMAvax IM and nivolumab IV over 60 minutes Treatment with CIMAvax repeats every 2 weeks for 4 doses during the loading phase and every 4 weeks during the maintenance phase in the absence of disease progression or unacceptable toxicity Courses for nivolumab repeat every 2 weeks in the absence of disease progression or unacceptable toxicity Patients in Study A with antibody titer 14000 at the end of the loading phase may receive CIMAvax IM every 8 or 12 weeks during the maintenance phase
PHASE II STUDY C Patients with PD-L1expression 50 receive CIMAvax IM and pembrolizumab IV over 30 minutes Treatment with CIMAvax repeats every 2 weeks for 4 doses during the loading phase and every 4 weeks during the maintenance phase in the absence of disease progression or unacceptable toxicity Courses for pembrolizumab repeat every 2 weeks for 2 years in the absence of disease progression or unacceptable toxicity
PHASE II STUDY D Patients with PD-L1 expression 50 after 4 cycles of induction chemotherapy with pembrolizumab receive CIMAvax IM and pembrolizumab IV over 30 minutes Treatment repeats every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 30 days for 120 days
I To identify the maximum dose of CIMAvax in combination with nivolumab based on dose limiting toxicities DLTs as assessed by Common Terminology Criteria for Adverse Events version 403 CTCAE version v 403 Phase I
II To evaluate the 12-month overall survival of CIMAvax combined with nivolumab in patients with advanced non-small cell lung cancer NSCLC Phase II-Study A
III To evaluate the 6-month progression free survival PFS of CIMAvax combined with nivolumab in patients with advanced recurrent squamous cell carcinoma of the head and neck Phase II-Study B
IV To evaluate the objective response rate of pembrolizumab in combination with CIMAvax as first-line therapy in patients with advanced NSCLC PD-L1 expression 50 Phase II-Study C
V To evaluate the 12-month PFS of pembrolizumab in combination with CIMAvax as maintenance therapy in patients with advanced squamous NSCLC PD-L1 expression 50 Phase II-Study D
VI To evaluate the 12-month PFS of pembrolizumab in combination with CIMAvax as maintenance therapy in patients with advanced NON-squamous NSCLC without EGFRALKROS-1KRAS mutations PD-L1 expression 50 Phase II- Study E
SECONDARY OBJECTIVES
I To assess the toxicity of CIMAvax combined with nivolumab using the Cancer Therapy Evaluation Program CTEP National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE version 403 Phase I
II Determine the preliminary efficacy of the combination of anti-PD1 therapy with CIMAvax Phase I III To evaluate progression free survival PFS for the combination of CIMAvax and nivolumab in patients with advanced NSCLC Phase II-Study A IV To evaluate the 12-month overall survival of patients with advanced recurrent squamous cell carcinoma of the head and neck who received nivolumab in combination with CIMAvax Phase II-Study B
V To evaluate the PFS and 12-month overall survival of CIMAvax in combination with pembrolizumab as first-line therapy in patients with advanced NSCLC PD-L1 expression 50 Phase II-Study C
VI To evaluate the PFS and overall survival of CIMAvax in combination with pembrolizumab as maintenance therapy in patients with advanced squamous NSCLC PD-L1 expression 50 Phase iI- Study D
VII To evaluate the PFS and overall survival of CIMAvax in combination with pembrolizumab as maintenance treatment in non-squamous NSCLC patients without EGFRALKROS-1KRAS mutations after induction chemoimmunotherapy PD-L1 expression 50Phase II - Study E
VIII To assess the toxicity of CIMAvax combined with nivlumab or pembrolizumab suing the CTEP NCI Common Terminology Criteria for Adverse Events CTCAE version 403 Phase II
TERTIARY OBJECTIVES
I To conduct correlative studies comparing blood EGF levels platelet levels markers of immune response and functionality of antibody response Phase I II To examine the association of EGFR total and activated PD-1 and PD-L1 expression and mutations in tumor tissue with biomarkers of genetic and immune response Phase I and II III Comparison of response assessment criteria for a prospective analysis immune-related ir Response Evaluation Criteria in Solid Tumors RECIST response assessment versus vs immune-related Response Criteria irRC vs RECIST 11 Phase I and II IV To characterize the blood EGF levels and other blood-based biomarkers of patients censored from the trial because of low titer response Phase II
OUTLINE This is a phase I dose escalation study of CIMAvax followed by a phase II study
LOADING PHASE I Patients receive CIMAvax intramuscularly IM and nivolumab intravenously IV over 60 minutes on day 1 Treatment repeats every 2 weeks for up to 4 doses in the absence of disease progression or unacceptable toxicity Within 4 weeks after the 4th dose patients receive CIMAvax IM at the same time as the next nivolumab dose
MAINTENANCE PHASE I Patients who do not experience a DLT receive CIMAvax every 4 weeks and nivolumab every 2 weeks
PHASE II STUDY A and B Patients receive CIMAvax IM and nivolumab IV over 60 minutes Treatment with CIMAvax repeats every 2 weeks for 4 doses during the loading phase and every 4 weeks during the maintenance phase in the absence of disease progression or unacceptable toxicity Courses for nivolumab repeat every 2 weeks in the absence of disease progression or unacceptable toxicity Patients in Study A with antibody titer 14000 at the end of the loading phase may receive CIMAvax IM every 8 or 12 weeks during the maintenance phase
PHASE II STUDY C Patients with PD-L1expression 50 receive CIMAvax IM and pembrolizumab IV over 30 minutes Treatment with CIMAvax repeats every 2 weeks for 4 doses during the loading phase and every 4 weeks during the maintenance phase in the absence of disease progression or unacceptable toxicity Courses for pembrolizumab repeat every 2 weeks for 2 years in the absence of disease progression or unacceptable toxicity
PHASE II STUDY D Patients with PD-L1 expression 50 after 4 cycles of induction chemotherapy with pembrolizumab receive CIMAvax IM and pembrolizumab IV over 30 minutes Treatment repeats every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 30 days for 120 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| I 286816 | OTHER | Roswell Park Cancer Institute | None |
| NCI-2016-01467 | REGISTRY | None | None |