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Bladder CancerPhase 2PANDORENCT03212651

Study Evaluating Neoadjuvant Pembrolizumab Monotherapy in Patients With Muscle-Invasive Bladder Cancer to Explore in Vivo the Mechanisms of Action of Pembrolizumab

A Phase 2 study testing Pembrolizumab in people with Bladder Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Completed

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

Official record
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Trial summary

monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2; Recent phase I trial provided evidence of activity of pembrolizumab in advanced platinum-resistant metastatic urothelial carcinoma; Recent phase 3 trial showed an overall… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteFrance
Study dates
17 Oct 2017to 13 Dec 2019
Phase
Phase 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

  • Be willing and able to provide written informed consent for the trial.
  • Be >/= 18 years of age on day of signing informed consent.
  • Histologically confirmed muscle invasive transitional cell carcinoma of the bladder (Note: urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed, provided that the extent of disease is confirmed via imaging and/or EUA. Patients with mixed histologies are required to have a dominant transitional cell pattern)
  • Clinical stage T2-T4a N0/X M0 disease according to TNM classification (within 4 weeks before registration)
  • Medically appropriate candidate for radical cystectomy as per urologic oncologist
  • Representative formalin-fixed paraffin embedded (FFPE) bladder tumor samples with an associated pathology report that are determined to be available and sufficient for central testing. If an insufficient amount of tumor tissue is available prior to the start of the screening phase, subjects must consent to allow the acquisition of additional tumor tissue for performance of central testing.
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  • Patients who refuse neoadjuvant cisplatin based chemotherapy or in whom neoadjuvant cisplatin based therapy is not appropriate for the following conditions:
  • ECOG performance status of 2
  • Creatinine clearance (calculated according to MDRD formula or measured) less than 1mL/s
  • CTCAE version 4.0, grade 2 or above audiometric hearing loss
  • CTCAE version 4.0, grade 2 or above peripheral neuropathy
  • Adequate bone marrow function obtained within 14 days before registration
  • Absolute neutrophil count ≥ 1,500/mm3
  • Hb ≥9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment)
  • Platelet count ≥ 100,000/mm3
  • Adequate organ function obtained within 14 days before registration
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN) or Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
  • Alkaline phosphatase ≤ 2 x upper limit of normal (ULN);
  • AST and ALT ≤2.5 x upper limit of normal (ULN);
  • Creatinine clearance > 30 ml/min according to MDRD formula
  • Albumin >2.5 mg/dL
  • Adequate Coagulation function
  • International Normalized ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  • Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 14 days prior to the first dose of study treatment. Both sexually active females and males (and their female partners) patients must agree to use two methods of highly effective contraception, one of them being a barrier method, or to abstain from sexual activity during the study and for at least 4 months after last study drug administration.
  • Patient affiliated to a social security regimen or beneficiary of the same

Who cannot join

  • Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks before the first dose of study treatment.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study treatment (except local/topical or aerosol steroids)
  • Has a known history of active TB (Bacillus Tuberculosis)
  • Hypersensitivity to pembrolizumab or any of its excipients
  • Has had a prior monoclonal antibody within 4 weeks or 5 halflife time (whatever the shortest) prior to the first dose of study treatment or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • Has had prior intra-venous chemotherapy, targeted small molecule therapy, or radiation therapy for bladder cancer
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  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  • Has an active autoimmune / immune mediated inflammatory disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study.
  • Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  • Positive for Human Immunodeficiency Virus (HIV) antibody testing
  • Active or chronic hepatitis C and/or B infection. Patients with past/resolved HBV infection (defined as the presence of antihepatitis B core antibody, IgG anti-HBs +) are eligible. HBV DNA should be obtained in these patients prior to the first dose of study treatment. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA
  • Has received a live attenuated vaccine within 30 days prior to the first dose of study treatment

Trial locations and contacts

1 site in 1 country.

France1 site

  • Gustave Roussy

    Villejuif, Val De Marne, 94805

Other trials in France

About this study

Official title: A Phase II Study Evaluating Neoadjuvant Pembrolizumab Monotherapy in Patients With Muscle-Invasive Bladder Cancer to Explore in Vivo the Mechanisms of Action of Pembrolizumab

monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2; Recent phase I trial provided evidence of activity of pembrolizumab in advanced platinum-resistant metastatic urothelial carcinoma; Recent phase 3 trial showed an overall survival benefit in patients treated with pembrolizumab in a trial comparing pembrolizumab to chemotherapy in patients who failed first-line platinum-based chemotherapy Neoadjuvant chemotherapy followed by radical cystectomy is the standard of care for cisplatinum-eligible non-metastatic MIBC patients; Many patients with MIBC are unfit for cisplatin-based combination treatment; Given its safety profile, pembrolizumab may be used in unfit patients; Neo-adjuvant setting is a unique opportunity to assess mechanisms of action of pembrolizumab in human

Conditions
Bladder Cancer
Being tested
Pembrolizumab
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

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

Study groups in NCT03212651
Study groupRoleWhat they receive
Patients with MIBC (Muscle Invasive Bladder Cancer)ExperimentalCisplatinum-ineligible patients with muscle-invasive bladder cancer
Receives: Drug: Pembrolizumab

What is being measured

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

  1. Pathologic complete response rate

    defined as the absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen in PD-L1 positive patients and PD-L1 negative patients

    Measured: Up to 1 month

Timeline

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

  1. First posted11 Jul 2017
  2. Study start17 Oct 2017
  3. Primary completion18 Jul 2019
  4. Study completion13 Dec 2019

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03212651
Sponsor's protocol ID
2016-002537-29
Other IDs
2016/2432, 2016
Acronym
PANDORE
Status last verified
Jan 2023
First submitted
6 Jul 2017
Last updated
20 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab in people with Bladder Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

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 26 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 20 Jan 2023. 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 France. 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 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 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?

Pathologic complete response rate (time frame: Up to 1 month). 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 NCT03212651.

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 20 Jan 2023.

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