CheckpOiNt Blockade For Inhibition of Relapsed Mesothelioma

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Brief Title

CheckpOiNt Blockade For Inhibition of Relapsed Mesothelioma

Official Title

CheckpOiNt Blockade For Inhibition of Relapsed Mesothelioma (CONFIRM): A Phase III Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy of Nivolumab in Relapsed Mesothelioma

Brief Summary

      The UK has the highest incidence of mesothelioma. The incidence has risen by 497% since the
      late 1970's and is increasing worldwide due to continued mining and use of asbestos. For
      patients with mesothelioma who have relapsed after taking pemetrexed and cisplatin, there is
      currently no standard treatment, making this an urgent unmet need. Recent trials in this area
      have not found an effective treatment that improves overall survival.

      Following a debate in the House of Lords, a national survey assessing the research priorities
      in mesothelioma found that 'exploiting the potential of immunotherapy' was a top priority.
      This trial was designed in response to that survey. It uses the immunotherapy agent nivolumab
      which blocks programmed cell death 1 (PD-1) receptor on activated T-cells (a type of white
      blood cell forming part of the immune system). Early research has found a dependency of
      mesothelioma on the PD-1 checkpoint. By attaching to PD-1, nivolumab blocks its action
      (checkpoint inhibition), preventing it from turning off the T-cell, and therefore allowing
      the immune system to work. PD-1 checkpoint inhibition has revolutionised the treatment of
      melanoma and it is hoped to be as effective in mesothelioma.

      This trial is a randomised, double blind placebo controlled trial of patients with
      mesothelioma who are second or third relapse following a platinum based chemotherapy
      treatment. Patients will be randomised in a 2:1 ratio (nivolumab: placebo).

      336 patients will be recruited from 25 UK centres with the last patient having a minimum of 6
      months follow up. All patients will be on treatment for 12 months unless they progress or
      withdrawal prior to this.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Overall survival

Secondary Outcome

 Overall response rate (modified RECIST or RECIST 1.1)

Condition

Mesothelioma

Intervention

Nivolumab

Study Arms / Comparison Groups

 Nivolumab
Description:  Nivolumab 240mg flat dose Q2W over 30 minutes IV until disease progression, to a maximum of 12 months

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

332

Start Date

March 28, 2017

Completion Date

July 2021

Primary Completion Date

July 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Signed and dated a REC-approved written informed consent form in accordance with
             regulatory and institutional guidelines. Must be obtained before the performance of
             any protocol-related procedures that are not part of normal patient care.

          -  Consent to provide tissue and blood samples for research

          -  Must be willing and able to comply with scheduled visits, treatment schedule,
             laboratory tests, and other requirements of the study

          -  Histological confirmation of mesothelioma (any subtype, pleural or peritoneal).

          -  Must have received treatment with at least one prior line of treatment. Prior
             maintenance therapy (e.g. avastin) is allowed and will not count as a line of therapy.
             Prior lines of antineoplastic therapy, including chemotherapy, surgical resection of
             lesions, radiation therapy, must be completed within 14 days of receiving nivolumab

          -  ECOG PS 0-1

          -  Age ≥18 years

          -  Expected survival of at least 12 weeks

          -  Radiologically assessable disease by modified RECIST (pleural mesothelioma) or RECIST
             1.1 (non-pleural mesothelioma or where measurements for mRECIST cannot be obtained).

          -  Evidence of disease progression by CT scan

          -  Prior palliative radiotherapy must have been completed at least 14 days prior to study
             drug administration

          -  Screening laboratory values must meet the following criteria within 48 hours prior to
             commencement of treatment:

             i) White blood cells ≥ 2 x 10^9/L ii) Neutrophils ≥1.5 x 10^9/L iii) Platelets ≥ 100
             X10^9/L iv) Haemoglobin ≥ 90 g/L v) Serum creatinine of ≤ 1.5 X ULN or creatinine
             clearance (CrCl) > 50 mL/minute (using Cockcroft/Gault formula) vi) AST ≤ 3 X ULN vii)
             ALT ≤ 3 X ULN viii) Total bilirubin ≤ 1.5 X ULN (except patients with Gilbert
             Syndrome, who must have total bilirubin < 51.3 μmol/L) 2 x 10^9/L

          -  Reproductive status

               1. Women of childbearing potential (WOCBP) must have a negative serum or urine
                  pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) at
                  enrolment and within 24 hours prior to the start of study drug.

               2. Women must not be breastfeeding.

               3. WOCBP must agree to follow instructions for method(s) of contraception for the
                  duration of treatment with nivolumab plus 5 half-lives of nivolumab (5 x
                  half-life=125 days) plus 30 days (duration of ovulatory cycle) for a total of 5
                  months post- treatment completion.

               4. Men who are sexually active with WOCBP must use any contraceptive method with a
                  failure rate of less than 1% per year. Men receiving nivolumab and who are
                  sexually active with WOCBP will be instructed to adhere to contraception for a
                  period of 7 months after the last dose of investigational product. Women who are
                  not of childbearing potential (i.e., who are postmenopausal or surgically sterile
                  as well as azoospermic men do not require contraception.

          -  Expected surivial of at least 12 weeks.

        Exclusion Criteria:

          -  Target Disease Exceptions

               1. Patients with untreated, symptomatic CNS metastases are excluded. Participants
                  are eligible if CNS metastases are adequately treated and participants are
                  neurologically returned to baseline (except for residual signs or symptoms
                  related to the CNS treatment) for at least 2 weeks prior to treatment assignment.
                  In addition, participants must be either off corticosteroids, or on a stable or
                  decreasing dose of <=10 mg daily prednisone (or equivalent) for at least 2 weeks
                  prior to treatment.

               2. Patients with carcinomatous meningitis are excluded.

          -  Physical and Laboratory Test Findings

               1. Known history of testing positive for human immunodeficiency virus (HIV) or known
                  acquired immunodeficiency syndrome (AIDS).

               2. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or
                  chronic infection.

          -  Allergies and Adverse Drug Reactions

             a) History of severe hypersensitivity reactions to other monoclonal antibodies

          -  Medical History and Concurrent Diseases

               1. Patients with active, known or suspected autoimmune disease.

               2. Patients with a condition requiring systemic treatment with either
                  corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive
                  medications within 14 days of the first dose of study drug administration.
                  Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily
                  prednisone or equivalent are permitted in the absence of active autoimmune
                  disease.

               3. Other active malignancy requiring concurrent intervention.

               4. Patients with previous malignancies (except non-melanoma skin cancers, and the
                  following in situ cancers: bladder, gastric, colon, endometrial,
                  cervical/dysplasia, melanoma or breast) are excluded unless a complete remission
                  was achieved at least 2 years prior to study entry AND no additional therapy is
                  required during the study period.

               5. Any serious or uncontrolled medical disorder or active infection that, in the
                  opinion of the investigator, may increase the risk associated with study
                  participation, study drug administration, or would impair the ability of the
                  patient to receive protocol therapy.

               6. All toxicities attributed to prior anti-cancer therapy other than alopecia and
                  fatigue not resolved to Grade 1 (NCI CTCAE version 4.03) or baseline before
                  administration of study drug.

               7. Patients who have not recovered from the effects of major surgery or significant
                  traumatic injury at least 14 days before the first dose of study treatment.

               8. Known alcohol or drug abuse.

               9. Patients who have received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2,
                  anti- CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody
                  or drug specifically targeting T-cell co-stimulation or checkpoint pathways) or
                  who have previously taken part in a randomised Bristol Myers Squibb (BMS)
                  clinical trial for nivolumab or ipilimumab including study CA209-743 (CheckMate
                  172) or in the CCTG trial of pembrolizumab (IND.227).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Dean Fennell, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03063450

Organization ID

22864

Secondary IDs

2016-003111-35

Responsible Party

Sponsor

Study Sponsor

University of Southampton

Collaborators

 Bristol-Myers Squibb

Study Sponsor

Dean Fennell, Principal Investigator, University of Leicester


Verification Date

January 2020