Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Transitional Cell Carcinoma

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Brief Title

Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Transitional Cell Carcinoma

Official Title

A Phase II Single Arm Clinical Trial of a Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Transitional Cell Carcinoma

Brief Summary

      TITAN-TCC (0416-ASG) is a Phase 2, open-label study of nivolumab (BMS-936558) monotherapy
      with additional nivolumab/ipilimumab "boost" cycles in previously untreated* and
      platinum-based pretreated, 2nd and 3rd line, advanced or metastatic transitional cell
      carcinoma subjects. Nivolumab is a fully human PD-1 antibody which blocks the respective
      immune checkpoint in a ligand (PD-L1/PD-L2) independent manner.

      [*Update from Jan-2020: First-line cohort was stopped and the inclusion of these patients was
      terminated]
    

Detailed Description

      This is a Phase 2, single arm study of a tailored immunotherapy approach with nivolumab in
      adult (≥ 18 years) subjects with previously untreated (1st line)* or pretreated (2nd and 3rd
      line), surgically unresectable or metastatic TCC (further designated "advanced TCC"). The
      study targets to recruit 130 untreated (1st line) and 120 pretreated (2nd / 3rd line)
      patients, respectively. Tumor tissue obtained at least 2 years prior to screening must be
      available for a central pathology assessment. Subjects must have advanced (not amenable to
      curative surgery or radiation) or metastatic TCC, and must not have received more than two
      prior platinum-based chemotherapies for the treatment of advanced TCC.

      [*Update from Jan-2020: First-line cohort was stopped and the inclusion of these patients was
      terminated. According protocol v.5.0 80 2nd/3rd-line patients need to be included]
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Objective Response Rate (ORR)

Secondary Outcome

 Remission Rates (RR)

Condition

Transitional Cell Carcinoma

Intervention

Nivolumab/Ipilimumab

Study Arms / Comparison Groups

 Nivolumab/Ipilimumab
Description:  Induction: Mono-Therapy with Nivolumab
If CR/PR: Nivolumab Maintenance Mono-Therapy
If SD/PD: Nivolumab/Ipilimumab "Boost 1+2"-Combination Therapy
If CR/PR: Nivolumab Maintenance Mono-Therapy
If SD/PD: Nivolumab/Ipilimumab "Boost 3+4"-Combination Therapy
If CR/PR/SD: Nivolumab Maintenance Mono-Therapy

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

Biological

Estimated Enrollment

169

Start Date

July 6, 2017

Completion Date

February 18, 2023

Primary Completion Date

September 16, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Signed Written Informed Consent

               -  Subjects or legally acceptable representatives must have signed and dated an
                  IRB/IEC approved written informed consent form in accordance with regulatory and
                  institutional guidelines. This must be obtained before the performance of any
                  protocol related procedures that are not part of normal subject care.

               -  Subjects or legally acceptable representatives must be willing and able to comply
                  with scheduled visits, treatment schedule, laboratory testing, and other
                  requirements of the study.

          -  Target Population

               -  Histological evidence of metastatic or surgically unresectable transitional cell
                  carcinoma of the bladder, urethra, ureter, or renal pelvis. Minor histologic
                  variants of transitional cell carcinoma (e.g. squamous cell, comprising <50 % of
                  the tumor overall) are acceptable.

               -  Subjects must have advanced or surgically unresectable TCC (cT4b, any N or any T,
                  N2-N3 or any M1) or having progressed during or after platinum-based first line
                  therapy and up to 1 further treatment line (2nd and 3rd line cohort). Subjects,
                  who have received neoadjuvant or adjuvant cisplatin based chemotherapy are
                  eligible and considered first line provided that progression has occurred >12
                  months from last therapy [for chemoradiation and adjuvant treatment] or >12
                  months from last surgery [for neoadjuvant treatment]; in all other patients who
                  received cisplatin based neoadjuvant and/or adjuvant chemotherapy and progression
                  within 12 months this will be considered one line of therapy. [*Update January
                  2020:First-line cohort has been stopped since 31-Jan-2019 and wont be restarted]

               -  KPS of at least 70% (See Appendix 1)

               -  Measurable disease as per RECIST v1.1 (See Appendix 2)

               -  Formalin-fixed paraffin embedded tumor tissue obtained within 2 years prior to
                  screening must be available and received by the central pathology (tumor block is
                  preferred, alternatively 15 unstained slides). Note that:

                    1. Fine Needle Aspiration [FNA] and bone metastases samples (without soft
                       tissue component) are not acceptable for submission).

                    2. Tumor lesions used for newly acquired biopsies should not be target lesions,
                       unless there are no other lesions.

          -  Age and Reproductive Status

               -  Males and Females, ≥ 18 years of age

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

               -  Women must not be breastfeeding

               -  Women of childbearing potential (WOCBP) must agree to follow instructions for
                  method(s) of contraception for a period of 30 days (duration of ovulatory cycle)
                  plus the time required for the investigational drug to undergo five half lives.
                  The terminal half lives of nivolumab and ipilimumab are up to 25 days and 18
                  days, respectively. WOCBP should use an adequate method to avoid pregnancy for 23
                  weeks (30 days plus the time required for nivolumab to undergo five half-lives)
                  after the last dose of investigational drug.

               -  Males who are sexually active with WOCBP must agree to follow instructions for
                  method(s) of contraception for a period of 90 days (duration of sperm turnover)
                  plus the time required for the investigational drug to undergo five half lives.
                  The terminal half lives of nivolumab and ipilimumab are up to 25 days and 18
                  days, respectively. Males who receive nivolumab combined with ipilimumab who are
                  sexually active with WOCBP must continue contraception for 31 weeks (90 days plus
                  the time required for nivolumab to undergo five half-lives) after the last dose
                  of investigational drug.

                    -  Comment: Azoospermic males and WOCBP who are continuously not heterosexually
                       active are exempt from contraceptive requirements. However, WOCBP must still
                       undergo pregnancy testing as described in this section.

        Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on
        the importance of pregnancy prevention and the implications of an unexpected pregnancy
        Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on
        the use of highly effective methods of contraception. Highly effective methods of
        contraception have a failure rate of < 1% when used consistently and correctly.

        At a minimum, subjects must agree to the use of two methods of contraception, with one
        method being highly effective and the other method being either highly effective or less
        effective as listed below:

        HIGHLY EFFECTIVE METHODS OF CONTRACEPTION

          -  Male condoms with spermicide

          -  Hormonal methods of contraception including combined oral contraceptive pills, vaginal
             ring, injectables, implants and intrauterine devices (IUDs) such as Mirena® by WOCBP
             subject or male subject's WOCBP partner. Female partners of male subjects
             participating in the study may use hormone based contraceptives as one of the
             acceptable methods of contraception since they will not be receiving study drug

          -  Nonhormonal IUDs, such as ParaGard®

          -  Tubal ligation

          -  Vasectomy

          -  Complete Abstinence*

               -  *Complete abstinence is defined as complete avoidance of heterosexual intercourse
                  and is an acceptable form of contraception for all study drugs. Subjects who
                  choose complete abstinence are not required to use a second method of
                  contraception, but female subjects must continue to have pregnancy tests.
                  Acceptable alternate methods of highly effective contraception must be discussed
                  in the event that the subject chooses to forego complete abstinence.

        LESS EFFECTIVE METHODS OF CONTRACEPTION

          -  Diaphragm with spermicide

          -  Cervical cap with spermicide

          -  Vaginal sponge

          -  Male Condom without spermicide

          -  Progestin only pills by WOCBP subject or male subject's WOCBP partner

          -  Female Condom*.

               -  * A male and female condom must not be used together

        Exclusion Criteria:

          -  Target Disease Exceptions

               -  Any history of or current CNS metastases. Baseline imaging of the brain by MRI
                  (preferred) or CT scan is required within 28 days prior to registration in
                  2nd/3rd line patients only.

          -  Medical History and Concurrent Diseases

               -  Prior systemic treatment with more than two different chemotherapy regimen
                  (Sequential chemotherapy as a planned sequence to optimize response will count as
                  1 regimen)

               -  Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti
                  CTLA 4 antibody, or any other antibody or drug specifically targeting T-cell
                  co-stimulation or checkpoint pathways.

               -  Any active or recent history of a known or suspected autoimmune disease or recent
                  history of a syndrome that required systemic corticosteroids (> 10 mg daily
                  prednisone equivalent) or immunosuppressive medications except for syndromes
                  which would not be expected to recur in the absence of an external trigger.
                  Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due
                  to autoimmune thyroiditis only requiring hormone replacement are permitted to
                  enroll.

               -  Any condition requiring systemic treatment with corticosteroids (> 10 mg daily
                  prednisone equivalents) or other immunosuppressive medications within 14 days
                  prior to first dose of study drug. Inhaled steroids and adrenal replacement
                  steroid doses > 10 mg daily prednisone equivalents are permitted in the absence
                  of active autoimmune disease.

               -  Prior malignancy active within the previous 3 years except for

                    1. locally curable cancers that have been apparently cured, such as basal or
                       squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ
                       of the prostate, cervix, or breast.

                    2. Patients in active surveillance for prostate cancer

               -  Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency
                  syndrome (AIDS).

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

               -  Known medical condition (eg, a condition associated with diarrhea or acute
                  diverticulitis) that, in the investigator's opinion, would increase the risk
                  associated with study participation or study drug administration or interfere
                  with the interpretation of safety results.

               -  Major surgery (eg, nephrectomy) less than 28 days prior to the first dose of
                  study drug.

               -  Anti-cancer therapy less than 28 days prior to the first dose of study drug or
                  palliative, focal radiation therapy less than 14 days prior to the first dose of
                  study drug.

               -  Presence of any toxicities attributed to prior anti-cancer therapy other than
                  neuropathy, alopecia and fatigue, that have not resolved to Grade 1 (NCI CTCAE
                  v4) or baseline before administration of study drug.

          -  Physical and Laboratory Test Findings

               -  Any of the following laboratory test findings:

                    1. WBC < 2,000/mm^3

                    2. Neutrophils < 1,500/mm^3

                    3. Platelets < 100,000/mm^3

                    4. AST or ALT > 3 x ULN (> 5 x ULN if liver metastases are present)

                    5. Total Bilirubin > 1.5 x ULN (except subjects with Gilbert Syndrome, who can
                       have total bilirubin < 3.0 mg/dL)

                    6. Serum creatinine > 1.5 x upper limit of normal (ULN) or creatinine clearance
                       < 40 mL/min (measured or calculated by Cockroft-Gault formula):

                         -  Female CrCl = [(140 - age in years) x weight in kg x 0.85] / [72 x
                            serum creatinine in mg/dL]

                         -  Male CrCl = [(140 - age in years) x weight in kg x 1.00] / [72 x serum
                            creatinine in mg/dL]

          -  Allergies and Adverse Drug Reaction

               -  History of severe hypersensitivity reaction to any monoclonal antibody or any
                  constituent of the products.

          -  Other Exclusion Criteria

               -  Prisoners or subjects who are involuntarily incarcerated

               -  Subjects who are compulsorily detained for treatment of either a psychiatric or
                  physical (eg, infectious disease) illness

               -  Participation in another clinical intervention trial 30 days prior to
                  registration

        Eligibility criteria for this study have been carefully considered to ensure the safety of
        the study subjects and that the results of the study can be used. It is imperative that
        subjects fully meet all eligibility criteria.

        Subject Re-enrollment: This study permits the re-enrollment of a subject that has
        discontinued the study as a pre-treatment failure (ie, subject has not been registered /
        has not been treated). If re-enrolled, the subject must be re-consented.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Marc-Oliver Grimm, Prof. Dr., , 

Location Countries

Austria

Location Countries

Austria

Administrative Informations


NCT ID

NCT03219775

Organization ID

0416-ASG


Responsible Party

Sponsor

Study Sponsor

AIO-Studien-gGmbH

Collaborators

 Bristol-Myers Squibb

Study Sponsor

Marc-Oliver Grimm, Prof. Dr., Principal Investigator, Universitätsklinikum Jena


Verification Date

April 2021