- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02452281
Pilot Study to Evaluate the Effects of a Vaccine (HSPPC-96) Combined With Ipilimumab in Patients With Advanced Melanoma
Phase I-II Pilot Study to Evaluate the Immune-mediated Effects of an Autologous Tumor-derived Heat Shock Protein-peptide Complex 96 (HSPPC-96) Combined With Ipilimumab in Patients With Therapeutically Unresectable Stage III or Stage IV Malignant Melanoma
Study Overview
Detailed Description
This is a randomized, open label, single-center, phase I-II trial to determine the safety, feasibility and immunogenicity of combination treatment of HSPPC-96 and ipilimumab in patients with therapeutically unresectable Stage III or Stage IV malignant melanoma.
The main purpose of this study is to assess whether the administration of the combination of ipilimumab and HSPPC-96 is safe. The rationale for combining the two treatments resides in their respective roles on the immune system as described below and based on the clinical experience collected so far. HSPPC-96 is able to initiate a tumor specific immune response that ipilimumab could theoretically amplify by blocking a checkpoint that naturally down-regulates T cells.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- UTHealth Memorial Hermann Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:Pre-surgery Inclusion criteria:
- Signed informed consent
- ≥ 18 years of age
- Stage III or Stage IV melanoma according to TNM staging criteria/AJCC version 7 determined by PET/MRI/CT scan
- ECOG score 0 or 1
- Life expectancy ≥6 months
- Candidate for surgical resection with viable melanoma tissue to ascertain ≥ 7 grams of viable cancer tissue (in aggregate), which is equivalent to a ≥ 2 cm lesion on CT/MRI or clinical examination
- Adequate cardiac function (≤ NYHA class II)
- Adequate bone marrow function, including: absolute granulocyte count (ANC) ≥ 1,500x106/L, absolute lymphocyte count (ALC) ≥ 500/mm3, platelets count ≥100,000 x 106/mm3. Adequate liver function including: serum glutamic oxaloacetic transaminases/aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the upper limit of institutional normal (IULNs), bilirubin ≤ 1.5 mg/dL or 25 µmol/L (SI units). Adequate renal function: BUN and Serum creatinine of ≤ 1.5 mg/dL or 130 µmol/L (SI units)
Female subjects of childbearing potential and fertile males must agree to use adequate contraception during the course of the study. Adequate contraception includes condoms with contraceptive foam; oral, implantable or injectable contraceptives; contraceptive patch; intrauterine device; diaphragm with spermicidal gel; or a sexual partner who is surgically sterilized or postmenopausal.
- Post-surgery Inclusion Criteria (must be completed within 4 weeks of surgery)
- Histologically and clinically confirmed Stage III and/or Stage IV malignant melanoma according to TNM Staging Criteria/AJCC version 7 confirmed by PET/CT scan
- Measurable disease for target lesion clinical and radiological monitoring
- ECOG score 0 or 1
- Adequate cardiac function (≤ NYHA class II)
- Adequate bone marrow function, liver, and renal function
- ≥ 6 doses of vaccine for clinical use
Exclusion Criteria: Pre-Surgery Exclusion Criteria:
- Primary mucosal or primary ocular melanomas
- Other malignancies treated within the last five years, except in situ cervix carcinoma or non-melanoma skin cancer
- Primary or secondary immunodeficiency (including immunosuppressive disease, or systemic use of corticosteroids or other immunosuppressive medications)
- Patients with history of HIV1 and 2, HTLV-1, HBV or active HCV.
- Patients with history of connective tissue disorders
- Prior ipilimumab or melanoma vaccine therapy
- Prior therapy with IL-2
- Prior chemotherapy, small molecule targeted therapy, interferon within 3 months prior to enrollment
- Prior investigational products administration within 4 weeks prior to enrollment
- Prior splenectomy
- Symptomatic CNS metastases or spinal cord compression
- Uncontrolled infection or other serious medical illnesses
- Any medical conditions that, in the opinion of the investigator, would preclude use of ipilimumab, including ipilimumab hypersensitivity
- Women who are pregnant or breast-feeding
Concurrent participation in investigational trials
- Post-surgery Exclusion Criteria (must be completed within 4 weeks of surgery):
- Emergence of contraindicated clinical condition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ipilimumab + HSPPC-96
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3 mg/kg, IV one day (a minimum of 12 hours and not more than 48 hours) before HSPPC-96 every 21-25 days for a total of 4 cycles.
Other Names:
25 μg by intradermal injection always 12 - 48 hours following ipilimumab on a weekly basis for the first 4 weeks and then every 3 weeks always 12 - 48 hours after ipilimumab; for at least 6 cycles of HSPPC-96 up to 12 doses.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All enrolled patients who receive at least one dose of study drug (HSPPC-96) will be evaluated for safety. (adverse events)
Time Frame: 2 years
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AEs will be coded by system organ class and preferred term using MedDRA.
AEs will be summarized using descriptive statistics.
Descriptive statistics will contain the number and percentage of patients who experience at least 1 AE, AEs related to study treatment, SAEs, SAEs related to study treatment, grade 3, 4 or 5 AEs, and grade 3, 4 or 5 AEs related to study treatment.
In addition, the number and percentage of patients who discontinue treatment for any reason, including discontinuation due to an AE, will be provided together with the number and percentage of patients who die.
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2 years
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• To assess immunological response by surrogate markers of immune response and modulation of tumor cellular microenvironment
Time Frame: 2 years
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All enrolled patients who receive at least one full cycle of treatment and have a baseline and at least one post treatment biological specimen available (tissue and/or blood) will be evaluated for immune response.
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: tumor evaluations every 12 weeks or until the date of first documented progression or death, whichever came first, assessed up to 24 months
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ORR defined by complete and partial responses.
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tumor evaluations every 12 weeks or until the date of first documented progression or death, whichever came first, assessed up to 24 months
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Progression Free Survival (PFS)
Time Frame: tumor evaluations every 12 weeks or until the date of first documented progression or death, whichever came first, assessed up to 24 months
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Time to recurrence is time from surgery until recurrence or last tumor evaluation without recurrence.
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tumor evaluations every 12 weeks or until the date of first documented progression or death, whichever came first, assessed up to 24 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rabih Said, MD, MPH, The University of Texas Health Science Center, Houston
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Ipilimumab
Other Study ID Numbers
- C-100-41
- HSC-MS-14-0070 (Other Identifier: UTHSC-H CPHS (IRB))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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