Study Stopped
Closed due to historically slow enrollment compounded by the COVID-19 pandemic.
A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma
An Open-label, Phase 1B Study of NEO-PV-01 + CD40 Agonist Antibody (APX005M) or Ipilimumab With Nivolumab in Patients With Advanced or Metastatic Melanoma
1 other identifier
interventional
22
1 country
8
Brief Summary
The primary purpose of this study is to demonstrate that the NEO-PV-01 vaccine, either with APX005M or ipilimumab, and nivolumab is safe for the treatment of patients with advanced or metastatic melanoma. The study will also investigate an alternative schedule for the administration of the NEO-PV-01 vaccine. Study interventions will be assessed by both clinical and immune responses to treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2018
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2018
CompletedFirst Posted
Study publicly available on registry
July 24, 2018
CompletedStudy Start
First participant enrolled
October 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2020
CompletedSeptember 3, 2020
September 1, 2020
1.6 years
July 13, 2018
September 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The rate of adverse events and severe adverse events leading to treatment discontinuation
Rate of adverse events and severe adverse events leading to treatment discontinuation and those adverse events and severe adverse events detected during symptom-directed physical examinations (changes in safety laboratory evaluations, physical examination findings. vital signs, and ECOG PS)
Baseline through 90 days after the last dose of nivolumab
Secondary Outcomes (6)
Objective Response Rate (ORR)
Baseline through 52 weeks
Clinical Benefit Rate
Baseline through 52 weeks
Duration of response
Baseline through 52 weeks
Response conversion rate
Baseline through 52 weeks
Progression free survival
Baseline through 52 weeks
- +1 more secondary outcomes
Other Outcomes (3)
Immune Responses
Baseline through 52 weeks
Overall response rate
Baseline through 52 weeks
Progression free survival
Baseline through 52 weeks
Study Arms (7)
NEO-PV-01 + adjuvant + nivolumab
EXPERIMENTALNivolumab at a dose of 240 mg will be administered by intravenous infusion (IV) every 2 weeks throughout the study. At Week 12, all patients, regardless of their disease status, will receive NEO-PV-01 + adjuvant administered subcutaneously.
Nivolumab + adjuvant
EXPERIMENTALNivolumab at a dose of 240 mg will be administered by intravenous infusion (IV) every 2 weeks throughout the study. At Week 12, all patients, regardless of their disease status, will receive Poly-ICLC (adjuvant) administered subcutaneously.
NEO-PV-01 + adjuvant + nivolumab on alternate schedule
EXPERIMENTALNivolumab at a dose of 240 mg will be administered by intravenous infusion (IV) every 2 weeks throughout the study. At Week 12, all patients, regardless of their disease status, will receive NEO-PV-01 + adjuvant, administered on an alternative schedule, subcutaneously.
NEO-PV-01 + adjuvant + nivolumab + APX005M
EXPERIMENTALNivolumab at a dose of 240 mg will be administered by intravenous infusion (IV) every 2 weeks throughout the study. At Week 12, all patients, regardless of their disease status, will receive NEO-PV-01 + adjuvant administered subcutaneously. Patients on this arm will also receive APX005M at a dose of 0.1 mg/kg administered by IV infusion at Week 12, Week 15, and Week 19.
Nivolumab + APX005M
EXPERIMENTALNivolumab at a dose of 240 mg will be administered by intravenous infusion (IV) every 2 weeks throughout the study. At Week 12, Week 15, and Week 19, all patients, regardless of their disease status, will receive APX005M at a dose of 0.1 mg/kg administered by IV infusion.
NEO-PV-01 + adjuvant + nivolumab + ipilimumab
EXPERIMENTALNivolumab at a dose of 240 mg administered by intravenous infusion (IV) every 2 weeks throughout the study. At Week 12, all patients, regardless of their disease status, will receive NEO-PV-01 + adjuvant administered subcutaneously. Patients on this arm will also receive ipilimumab at a dose of 1.0 mg/kg administered by IV infusion at Week 12 and Week 19.
Nivolumab + ipilimumab
EXPERIMENTALNivolumab at a dose of 240 mg will be administered by intravenous infusion (IV) every 2 weeks throughout the study. At Week 12 and Week 19, all patients, regardless of their disease status, will receive ipilimumab at a dose of 1.0 mg/kg administered by IV infusion.
Interventions
Personal Cancer Vaccine
monoclonal antibody against PD-1
immune adjuvant
monoclonal agonist antibody against CD40
monoclonal antibody against CTLA4
Eligibility Criteria
You may qualify if:
- Willing and able to give written informed consent.
- Age ≥ 18 years.
- Have cytologically or histologically confirmed advanced or metastatic melanoma and having received no prior systemic therapy for metastatic disease.
- Have at least 1 site of disease measurable by RECIST 1.1 that has not been treated with local therapy within 6 months of study treatment. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Have at least 1 site of disease accessible to repeat biopsies for tumor sequencing and immunological analysis. This site may be a target lesion as long as it will not become unmeasurable by the biopsy procedure.
- Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 with an anticipated life expectancy of \> 6 months.
- Screening laboratory values must meet the following criteria and should be obtained within 30 days (or 45 days if a biopsy is repeated) prior to study treatment:
- White blood cell (WBC) count ≥ 3 × 103/µL
- Platelet count ≥ 100 × 103/µL
- Hemoglobin \> 9 g/dL
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN for patients with liver metastases
- Total bilirubin ≤ 1.5 × ULN (except in patients with Gilbert Syndrome who can have total bilirubin \< 3.0 mg/dL).
- Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female patients of childbearing potential must be willing to use an adequate method of contraception, as outlined in the protocol, for the course of the study through 120 days after last dose of study medication.
- +1 more criteria
You may not qualify if:
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of first dose of treatment.
- Received any systemic therapy for advanced or metastatic cancer treatment including immunotherapeutic agents such as anti-programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-CD40, or anti-cytotoxic T-lymphocyte-associated antigen 4 (anti-CTLA-4) antibody therapy.
- Have had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from AE due to agents administered more than 4 weeks earlier.
- Have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 30 days prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to a previously administered agent.
- Note: Patients with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study.
- Note: If patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Received radiation therapy at the biopsy sites.
- Received prior tyrosine kinase inhibitor therapy or palliative radiation within 7 days of Cycle 1/Day 1.
- Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging \[using the identical imaging modality for each assessment, either magnetic resonance imaging (MRI) or computed tomography (CT) scan\] for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.
- Have active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
- Received a live vaccination within 30 days of planned treatment start date.
- Have an active infection requiring systemic therapy.
- Have a history of sensitivity or allergy to mAbs or immunoglobulin G (IgG).
- Have a history of allogeneic bone marrow transplantation.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioNTech US Inc.lead
- Apexigen America, Inc.collaborator
Study Sites (8)
HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
University of Colorado Denver
Denver, Colorado, 80045, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mark DeMario, MD
BioNTech US Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2018
First Posted
July 24, 2018
Study Start
October 8, 2018
Primary Completion
May 5, 2020
Study Completion
August 11, 2020
Last Updated
September 3, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share