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Urinary Bladder CancerPhase 1NCT02897765

A Personal Cancer Vaccine (NEO-PV-01) w/ Nivolumab for Patients With Melanoma, Lung Cancer or Bladder Cancer

A Phase 1 study testing NEO-PV-01, Nivolumab and Adjuvant in people with Urinary Bladder Cancer and Bladder Tumors, run by BioNTech US Inc. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate if the treatment with NEO-PV-01 + adjuvant in combination with nivolumab is safe and useful for patients with certain types of cancer. The study also will investigate if NEO-PV-01 + adjuvant with nivolumab may represent a substantial improvement over other available therapies… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NEO-PV-01, Nivolumab and Adjuvant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
9 sitesUnited States
Study dates
Oct 2016to May 2020
Phase
Phase 1
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

  • Willing and able to give written informed consent.
  • Have histologically confirmed unresectable or metastatic melanoma having received no more than one prior systemic therapy for the metastatic disease (eg. ipilumamab and/or BRAF inhibitor); unresectable or metastatic smoking-associated NSCLC having received no more than one prior systemic therapy for the metastatic disease (eg standard of care chemotherapy, as appropriate); unresectable or metastatic transitional cell carcinoma of the bladder, urethra, ureter or renal pelvis having received no more than one prior systemic therapy for the metastatic disease.
  • Have at least one site of disease measurable disease by RECIST v1.1 that has not been treated with local therapy within 6 months of study treatment. This can be the site for initial or repeat biopsies as long as it will remain measurable following biopsy.
  • At least one site of disease must be accessible to provide repeat biopsies for tumor tissue for sequence and immunological analysis.
  • Have ECOG PS of 0 or 1 with an anticipated life expectancy of > 6 months.
  • Age ≥ 18 years.
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  • Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicity see below limits for inclusion) or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03, Grade of 0 or 1, except for toxicities not considered a safety risk (e.g., alopecia or vitiligo).
  • Screening laboratory values must meet the following criteria and should be obtained within 30 days (45 if biopsy is repeated) prior to study treatment:
  • White blood cell (WBC) count ≥ 3 × 10e3/µL
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10e3/µL
  • Absolute lymphocyte count (ALC) ≥ 1 × 10e3/µL
  • Platelet count ≥ 100 × 10e3/µL
  • Hemoglobin > 9 g/dL
  • Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 40 mL/min/1.73 m
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN
  • Total bilirubin ≤ 1.5 × ULN (except in patients with Gilbert Syndrome who can have total bilirubin < 3.0 mg/dL).
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 7 days prior to the start of nivolumab.
  • Female participants, who are not free from menses for >2 years, post hysterectomy / oophorectomy, or surgically sterilized, must be willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from sexual activity throughout the study, from screening through 5 months after the last dose of study treatment (including nivolumab single agent). Approved contraceptive methods include, for example: intrauterine device, diaphragm with spermicide, cervical cap with spermicide, male condom with spermicide, or female condom with spermicide. Spermicides alone are not an acceptable method of contraception.
  • Men who are sexually active with women of child bearing potential must agree to use a condom from screening through 7 months after the last dose of study treatment (including nivolumab single agent).
  • For NSCLC, patients must have a minimum of a 10 pack-year smoking history.

Who cannot join

  • Received therapy with any immunotherapeutic agents including, but not limited to, any anti-PD1 or anti-PDL1 antibody therapy, with these exceptions: Melanoma patients having received and progressed on anti-CTLA4 (cyctotoxic T lymphocyte-associated antigen 4) may participate in the trial; Bladder cancer patients having received intra-vesical BCG may participate in the trial.
  • Received systemic anti-cancer therapy within 30 days of Week 0, Day 11 of study treatment.
  • Have untreated central nervous system (CNS) metastases. Patients are eligible for study participation if CNS metastases are adequately treated and patients are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 60 days prior to consent. In addition, patients must either be off corticosteroids, or on a stable or decreasing dose of 10 mg daily prednisone (or equivalent) for at least 60 days prior to consent.
  • Received non-oncology vaccine therapy for prevention of infectious diseases during the 4-week period prior to first dose of nivolumab therapy. Patients may not receive any non-oncology vaccine therapy during the period of NEO-PV-01 + adjuvant or nivolumab administration and until at least 8 weeks after the last dose of the booster vaccine. Annual influenza vaccines are allowed during screening and pre-treatment but not during nivolumab or NEO-PV-01 + adjuvant dosing.
  • Received radiation therapy within 4 weeks prior to Week 0, Day 1 of study treatment. Patients may not receive or have received any radiation therapy at the biopsy sites.
  • Have an active or history of autoimmune disease (known or suspected). Exceptions are permitted for vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition requiring only hormone replacement, psoriasis not on systemic treatment, or conditions not expected to recur in the absence of an external trigger.
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  • Have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 15 days prior to the first dose of study treatment (nivolumab). Inhaled or topical steroids and adrenal replacement doses (≤ 10 mg daily prednisone equivalents) are permitted in the absence of active autoimmune disease.
  • Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, or life-threatening illnesses unrelated to cancer.
  • Have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring treatment, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  • Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs.
  • Have a planned major surgery.
  • Pregnant women are excluded from this study because nivolumab, personalized neoantigen peptides, and Poly-ICLC are agents with unknown risks to the developing fetus.
  • Nursing women are excluded from this study because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with nivolumab, personalized neoantigen peptides, and Poly-ICLC.
  • Have a history of an invasive metastatic disease, except for the following circumstances: individuals with a history of invasive metastatic disease are eligible if they have been disease-free for at least 2 years and are deemed by the Investigator to be at low risk for recurrence of that metastatic disease; individuals with the following cancers are eligible if diagnosed and treated: carcinoma in situ of the breast, oral cavity or cervix, localized prostate cancer, basal cell or squamous cell carcinoma of the skin.
  • Mucosal melanoma and uvueal melanoma.
  • Patients with NSCLC and known anaplastic lymphoma kinase (ALK) translocations or epidermal growth factor receptor (EGFR) mutations who have not received prior treatment with ALK or EGFR inhibitor.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Center

    Boston, Massachusetts, 02115

  • City of Hope

    Duarte, California, 91010

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • UCLA Medical Center

    Los Angeles, California, 90095

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of California San Francisco

    San Francisco, California, 94143

  • Washington University in St. Louis

    St Louis, Missouri, 63130

Other trials in United States

About this study

Official title: An Open-label, Phase IB Study of NEO-PV-01 + Adjuvant With Nivolumab in Patients With Melanoma, Non-Small Cell Lung Carcinoma or Transitional Cell Carcinoma of the Bladder

The purpose of this study is to evaluate if the treatment with NEO-PV-01 + adjuvant in combination with nivolumab is safe and useful for patients with certain types of cancer. The study also will investigate if NEO-PV-01 + adjuvant with nivolumab may represent a substantial improvement over other available therapies such as nivolumab alone. All eligible patients will receive NEO-PV-01 + adjuvant and nivolumab while on this trial.

Read the detailed description

This clinical trial will enroll patients with metastatic or advanced melanoma, lung, or bladder cancer. The three agents being used in this study are:

  • A new, investigational, personal cancer vaccine called "NEO-PV-01"
  • Poly-ICLC (Hiltonol), an investigational adjuvant that is used to help stimulate the immune system
  • A cancer drug called nivolumab (OPDIVO®)

These agents are considered immunotherapy and work by stimulating the immune system to fight cancer. NEO-PV-01 is a truly personal vaccine therapy in that it is custom designed and manufactured to include targets for the immune system that are present uniquely on an individual's cancer. Poly-ICLC is an adjuvant that helps stimulate the immune system and make the vaccine, NEO-PV-01 more effective. Nivolumab helps T-cells, a certain type of immune cell, that recognize these targets to reach and attack the tumor. Nivolumab is in clinical development for treatment of bladder cancer and is approved by the FDA (the U.S. Food and Drug Administration) for the treatment of some lung, skin, kidney, and blood cancers.

The purpose of this study is to find out if treatment with NEO-PV-01 + adjuvant in combination with nivolumab is safe and effective for patients with melanoma, lung, or bladder cancer. The study also will see if NEO-PV-01 vaccine + adjuvant with nivolumab can improve responses compared to available therapies such as nivolumab monotherapy The side effects of NEO-PV-01 + adjuvant and nivolumab will be monitored and additional research tests will be done to assess the immune response against each individual's cancer.

Being tested
NEO-PV-01, Nivolumab, Adjuvant
Keywords
Checkpoint Inhibitor, Immunotherapy, Personal Vaccine, Neoantigen, Poly-ICLC, Peptide
Medical subject headings
Urinary Bladder Neoplasms, Melanoma, Skin Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

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

  • NEO-PV-01Biological

    Also called Personal cancer vaccine

    Personal cancer vaccine

  • NivolumabBiological

    Also called Opdivo

    monoclonal antibody against PD1

  • AdjuvantOther

    Also called Hiltonol, poly-ICLC

    immune adjuvant

Study groups in NCT02897765
Study groupRoleWhat they receive
Drug: NEO-PV-01 + Nivolumab + AdjuvantExperimentalNivolumab at a dose of 240 mg administered by intravenous (IV) infusion over 30 minutes every two weeks. At Week 12, all patients, regardless of their disease status, will receive NEO-PV-01 + adjuvant administered subcutaneously (one vial of pooled peptides per injection site) in up to four distinct sites (each extremity or flanks) while continuing therapy with nivolumab.
Receives: Biological: NEO-PV-01; Biological: Nivolumab; Other: Adjuvant

What is being measured

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

  1. Rate of adverse events including SAEs and AEs leading to treatment discontinuation

    Rate of adverse events including SAEs and AEs leading to treatment discontinuation

    Measured: Baseline through 100 days after last dose of nivolumab

  2. Rate of adverse events including SAEs and AEs leading to changes in safety laboratory evaluations

    Rate of adverse events including SAEs and AEs leading to changes in safety laboratory evaluations

    Measured: Baseline through 100 days after last dose of nivolumab

  3. Rate of adverse events including SAEs and AEs leading to physical examination findings

    Rate of adverse events including SAEs and AEs leading to physical examination findings

    Measured: Baseline through 100 days after last dose of nivolumab

  4. Rate of adverse events including SAEs and AEs leading to vital signs findings

    Rate of adverse events including SAEs and AEs leading to vital signs findings

    Measured: Baseline through 100 days after last dose of nivolumab

  5. Rate of adverse events including SAEs and AEs leading to changes in ECOG status

    Rate of adverse events including SAEs and AEs leading to changes in ECOG status

    Measured: Baseline through 100 days after last dose of nivolumab

Secondary outcomes (6)

  1. Objective response rate (ORR)

    Objective response rate (ORR), defined as the proportion of patients who achieve complete response (CR) or partial response (PR) based on Response Criteria in Solid Tumors (RECIST) v1.1.

    Measured: Baseline through 104 weeks

  2. Duration of response (DOR)

    Duration of response (DOR), defined as the date of the first documentation of a confirmed response to the date of the first documented PD.

    Measured: Baseline through 104 weeks

  3. Clinical benefit rate (CBR)

    Clinical benefit rate (CBR), defined as the proportion of patients who achieve CR, PR, or stable disease (SD) based on RECIST v1.1

    Measured: Baseline through 104 weeks

  4. Response conversion rate (RCR)

    Response conversion rate (RCR) of NEO-PV-01 + adjuvant with nivolumab at Week 24 defined as the proportion of patients who improve in RECIST v1.1 category from Week 12 to Week 24 (e.g., PD to SD/PR/CR, SD to PR/CR, PR to CR).

    Measured: Baseline through 104 weeks

  5. Progression-free survival (PFS)

    Progression-free survival (PFS), defined as the time from the date of first dosing to the date of first documented PD or death.

    Measured: Baseline through 104 weeks

  6. Overall survival (OS)

    Overall survival (OS), defined from the date of enrollment and death from any cause.

    Measured: Baseline through 104 weeks

Timeline

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

  1. First posted13 Sep 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionFeb 2019
  4. Study completionMay 2020

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02897765
Sponsor's protocol ID
NT-001
Status last verified
Feb 2021
First submitted
12 Aug 2016
Last updated
25 Feb 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Poran A, Scherer J, Bushway ME, Besada R, Balogh KN, Wanamaker A, Williams RG, Prabhakara J, Ott PA, Hu-Lieskovan S, Khondker ZS, Gaynor RB, Rooney MS, Srinivasan L. Combined TCR Repertoire Profiles and Blood Cell Phenotypes Predict Melanoma Patient Response to Personalized Neoantigen Therapy plus Anti-PD-1. Cell Rep Med. 2020 Nov 17;1(8):100141. doi: 10.1016/j.xcrm.2020.100141. eCollection 2020 Nov 17.

    PubMed 33294862

  • Ott PA, Hu-Lieskovan S, Chmielowski B, Govindan R, Naing A, Bhardwaj N, Margolin K, Awad MM, Hellmann MD, Lin JJ, Friedlander T, Bushway ME, Balogh KN, Sciuto TE, Kohler V, Turnbull SJ, Besada R, Curran RR, Trapp B, Scherer J, Poran A, Harjanto D, Barthelme D, Ting YS, Dong JZ, Ware Y, Huang Y, Huang Z, Wanamaker A, Cleary LD, Moles MA, Manson K, Greshock J, Khondker ZS, Fritsch E, Rooney MS, DeMario M, Gaynor RB, Srinivasan L. A Phase Ib Trial of Personalized Neoantigen Therapy Plus Anti-PD-1 in Patients with Advanced Melanoma, Non-small Cell Lung Cancer, or Bladder Cancer. Cell. 2020 Oct 15;183(2):347-362.e24. doi: 10.1016/j.cell.2020.08.053.

    PubMed 33064988

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NEO-PV-01, Nivolumab and Adjuvant in people with Urinary Bladder Cancer and Bladder Tumors, run by BioNTech US Inc. at 9 sites 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 20 inclusion and 16 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: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Rate of adverse events including SAEs and AEs leading to treatment discontinuation (time frame: Baseline through 100 days after last dose of nivolumab). The study lists 5 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 NCT02897765, which also lists 2 linked publications.

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 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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