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MelanomaPhase 1/2NCT02452281

Pilot Study to Evaluate the Effects of a Vaccine (HSPPC-96) Combined With Ipilimumab in Patients With Advanced Melanoma

A Phase 1/2 study testing ipilimumab and HSPPC-96 in people with Melanoma, run by Rabih Said at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this research study is to see if the combination of HSPPC-96 and ipilimumab is safe and effective in the treatment of advanced melanoma. HSPPC-96 is an investigational vaccine created from tissue from the patient's tumor. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
ipilimumab and HSPPC-96
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Dec 2015to Dec 2018
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UTHealth Memorial Hermann Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: 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

The purpose of this research study is to see if the combination of HSPPC-96 and ipilimumab is safe and effective in the treatment of advanced melanoma. HSPPC-96 is an investigational vaccine created from tissue from the patient's tumor. The vaccine is designed to capture the cancer's "fingerprint." Injection of the vaccine may cause the patient's immune system to recognize and attack any cells with the specific cancer fingerprint. Ipilimumab is a drug approved by the FDA for the treatment of metastatic melanoma that boosts immune response.

Read the 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.

Conditions
Melanoma
Being tested
ipilimumab, HSPPC-96
Keywords
Therapeutically Unresectable, Stage III or Stage IV, Malignant Melanoma, Advanced Melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ipilimumabDrug

    Also called Yervoy ®

    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.

  • HSPPC-96Drug

    Also called heat shock protein-peptide complex 96; Prophage; Vitespen

    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.

Study groups in NCT02452281
Study groupRoleWhat they receive
ipilimumab + HSPPC-96Experimental* Ipilimumab is administered intravenously at a dose of 3 mg/kg 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. * HSPPC-96 is administered at a dose of 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. * Length of Treatment: 4 cycles of ipilimumab and at least 6 cycles of HSPPC-96 up to 12 doses. * Booster doses of HSPCC-96 following 6 administrations on subsequent cycles will be administered every 21-23 days according to availability of vaccine.
Receives: Drug: ipilimumab; Drug: HSPPC-96

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All enrolled patients who receive at least one dose of study drug (HSPPC-96) will be evaluated for safety. (adverse events)

    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.

    Measured: 2 years

  2. • To assess immunological response by surrogate markers of immune response and modulation of tumor cellular microenvironment

    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.

    Measured: 2 years

Secondary outcomes (2)

  1. Objective Response Rate (ORR)

    ORR defined by complete and partial responses.

    Measured: tumor evaluations every 12 weeks or until the date of first documented progression or death, whichever came first, assessed up to 24 months

  2. Progression Free Survival (PFS)

    Time to recurrence is time from surgery until recurrence or last tumor evaluation without recurrence.

    Measured: tumor evaluations every 12 weeks or until the date of first documented progression or death, whichever came first, assessed up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Why it stopped: PI departure, operational issues

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02452281
Sponsor's protocol ID
C-100-41
Other IDs
HSC-MS-14-0070
Status last verified
Jan 2016
First submitted
13 May 2015
Last updated
25 Jan 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ipilimumab and HSPPC-96 in people with Melanoma, run by Rabih Said at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02452281.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2016; AzTrials last refreshed its copy on 6 Nov 2026.

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