Improve Checkpoint-blockade Response in Advanced Urothelial Cancer

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Brief Title

Improve Checkpoint-blockade Response in Advanced Urothelial Cancer

Official Title

ICRA (Improve Checkpoint-blockade Response in Advanced Urothelial Cancer), an Adaptive Clinical Study to Determine Efficacy of Combining Weekly Paclitaxel With Tremelimumab +/- Durvalumab (MEDI4736)

Brief Summary

      This trial will include metastatic urothelial carcinoma patients who progressed during or
      after treatment with anti-PD(L)1 therapy and have been treated by a platinum-containing
      regimen, or are cisplatin-ineligible. Patients will receive either paclitaxel in combination
      with durvalumab (anti-PDL-1) and a single dose (300 mg) of tremelimumab (anti-CTLA4), or
      paclitaxel with only a high dose of tremelimumab (750 mg). Tremelimumab (750 mg), without
      paclitaxel will be used as a comparison arm.

      A run-in safety phase will be followed by a non-comparative 3-arm randomized study with a
      Simon's 2-stage optimal design.
    

Detailed Description

      This trial will include metastatic urothelial carcinoma patients who progressed during or
      after treatment with anti-PD(L)1 therapy and have been treated by a platinum-containing
      regimen, or are cisplatin-ineligible.

      A run-in safety phase will be followed by a non-comparative 3-arm randomized study with a
      Simon's 2-stage optimal design.

      Screening:

      Before enrollment, patients will need to complete the following screening procedures (among
      other assessments):

        -  Baseline evaluation by CT chest/abdomen/pelvis (<4 weeks)

        -  Laboratory assessment

        -  Tissue biopsy (in at least 6 patients per arm)

      Run-in phase-1 (R1): n=3 patients will be treated with:

        -  paclitaxel 70 mg/m2 on day 1, 8, 15 of cycles 1-6

        -  tremelimumab 75 mg on day 1 of cycles 2-6 and then every 12 weeks until week 45

      Run-in phase-2 (R2): n=3 patients will be treated with:

        -  paclitaxel 70 mg/m2 on day 1, 8, 15 of cycles 1-6

        -  tremelimumab 225 mg on day 1 of cycles 2-6 and then every 12 weeks until week 45

      Run-in phase-3 (R3): n=2 x 3 patients will be randomized over 2 arms:

        -  paclitaxel 70 mg/m2 on day 1, 8, 15 of cycles 1-6

        -  tremelimumab 750 mg on day 1 of cycles 2-6 and then every 12 weeks until week 45 OR

        -  paclitaxel 70 mg/m2 on day 1, 8, 15 of cycles 1-6

        -  tremelimumab 75 mg on day 1 of cycles 2-5

        -  durvalumab 1500 mg on day 1 of cycles 2-12, every four weeks (until week 49)

      Run-in phase-4 (R4): n=3 patients will be treated with:

        -  paclitaxel 70 mg/m2 on day 1, 8, 15 of cycles 1-6

        -  tremelimumab 300 mg once on day 1 of cycle 2

        -  durvalumab 1500 mg on day 1 of cycles 2-12, every four weeks (until week 49)

      Enrollment will start with the first run-in cohort (R1) and will be halted after inclusion of
      the 3rd patient, until 60 days after start of treatment of this patient. Stopping rules are
      defined in the section 6.3 of the protocol. In case unexpected toxicity occurs (either as
      defined by the stopping rules or otherwise unexpected severe toxicity), the study team will
      discuss with the IDMC whether expansion to include 3 additional subjects is warranted. If no
      unexpected toxicity has occurred within 60 days after initiation of treatment of the 3rd
      patient of R1, enrollment for R2 will begin in a similar fashion. If 2 or more
      nonhematological toxicities as described in section 6.3 "Definition of DLT" occur in R1 or
      R2, enrollment will be suspended until the IDMC has formulated an advice. After this advice,
      the sponsor will decide on continuation.

      If no unexpected toxicity has occurred within 60 days after initiation of treatment of the
      3rd patient of R2, the study will continue with a third run-in cohort (R3) where patients
      will be randomized over 2 arms (R3A and R3B), n=3 per arm. If no unexpected toxicity has
      occurred within 60 days after initiation of treatment of the 3rd patient in arm R3A, this arm
      will be continued into the main study phase (as Arm A). If unacceptable toxicity is observed
      at either 225 mg or 750 mg of tremelimumab during one of the run-in cohorts, a lower dose
      level can be used in the main study. In addition, after completion of R3A and continuation in
      the main study phase, a control arm (Arm C) will be initiated where patients will be treated
      with tremelimumab monotherapy (without paclitaxel).

      If no unexpected toxicity has occurred within 60 days after initiation of treatment of the
      3rd patient of R3B, enrollment for run-in cohort R4 will begin in a similar fashion as
      described for the earlier run-in cohorts. Expansion arms A and C will be paused while this
      cohort is enrolling. If no unexpected toxicity has occurred within 60 days after initiation
      of treatment of the 3rd patient of R4, enrollment for arm R4 will be continued into the main
      study phase (as Arm B). If unacceptable toxicity is observed at 300 mg of tremelimumab in
      combination with 1500mg durvalumab, arm B, combining paclitaxel, tremelimumab and durvalumab,
      will be discontinued.

      Main study:

      Arm A:

        -  paclitaxel 70 mg/m2 on day 1, 8, 15 of cycles 1-6

        -  tremelimumab 750 mg on day 1 of cycles 2-6 and then every 12 weeks until week 45

      Arm B:

        -  paclitaxel 70 mg/m2 on day 1, 8, 15 of cycles 1-6

        -  tremelimumab 300 mg once on day 1 of cycle 2

        -  durvalumab 1500 mg on day 1 of cycles 2-12, every four weeks (until week 49)

      Arm C (control arm):

      • tremelimumab 750 mg on day 1 of cycles 1-5 and then every 12 weeks until week 41

      Enrollment will be halted when 12 patients are enrolled in each arm; this will include
      patients treated in R3 at the dose level used in the main study. These patients will be
      included in the efficacy analysis.

      After the last patient has had the second evaluation scan, the Objective Response Rate (ORR)
      of each treatment arm will be evaluated. If one or more of the experimental arms has ≥2
      responses, the study team will discuss continuation of one of the experimental arms to n=20
      with the IDMC. In case 2 responses are seen in one of the arms prior to the second evaluation
      scan of the last patient, a decision on expansion of that arm may be recommended earlier.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Overall response rate (ORR), defined as the proportion of participants whose confirmed best overall response is either a PR or CR after treatment with paclitaxel and a high dose of tremelimumab based upon the RECIST v1.1 guidelines.

Secondary Outcome

 Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Condition

Urothelial Carcinoma

Intervention

Tremelimumab

Study Arms / Comparison Groups

 Tremelimumab 75 (R1)
Description:  Run-in phase-1 (R1): n=3 patients will be treated with:
paclitaxel 70 mg/m2 on day 1, 8, 15 of cycles 1-6
tremelimumab 75 mg on day 1 of cycles 2-6 and then every 12 weeks until week 45

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

53

Start Date

May 1, 2019

Completion Date

February 1, 2023

Primary Completion Date

November 1, 2022

Eligibility Criteria

        Inclusion Criteria:

        For inclusion in the study, patients should fulfill the following criteria:

          1. Capable of giving signed informed consent which includes compliance with the
             requirements and restrictions listed in the informed consent form (ICF) and in this
             protocol. Written informed consent and any locally required authorization (eg,
             European Union [EU] Data Privacy Directive) obtained from the patient/legal
             representative prior to performing any protocol-related procedures, including
             screening evaluations.

          2. Patients with histologically or cytologically documented metastatic or irresectable
             (i.e. T4b, N1-3 and/or M1a/b) urothelial cell carcinoma (including renal pelvis,
             ureters, urinary bladder, and urethra).

          3. Patients ineligible for cisplatin-based chemotherapy OR previous treatment with
             platinum-based chemotherapy, either in the neo-adjuvant setting or in any other
             setting. This is defined as progression on or after at least 2 cycles of
             platinum-based chemotherapy (e.g. MVAC, cisplatin/gemcitabine,
             carpoblatin/gemcitabine). Patients who had to stop platinum-based therapy because of
             toxicity after at least 2 cycles are eligible if progressive disease has been
             confirmed.

          4. Previous treatment with anti-PD(L)1 immunotherapy. The following conditions apply for
             inclusion:

               1. Must not have experienced a toxicity that led to permanent discontinuation of
                  prior anti-PD(L)1 immunotherapy;

               2. All treatment-related AEs while receiving prior anti-PD(L)1 immunotherapy must
                  have completely resolved or resolved to baseline prior to screening for this
                  study;

               3. Must not have experienced a ≥Grade 3 immune related AE or an immune related
                  neurologic or ocular AE of any grade while receiving prior anti-PD(L)1
                  immunotherapy;

               4. Patients with endocrine AE of ≤Grade 2 are permitted to enroll if the AEs are
                  stably maintained on appropriate replacement therapy and are asymptomatic;

               5. Must not have required the use of additional immunosuppression other than
                  corticosteroids for the management of an AE, not have experienced recurrence of
                  an AE if re-challenged, and not currently require maintenance doses of >10 mg
                  prednisone or equivalent per day;

          5. At least 1 lesion, not previously irradiated, that can be accurately measured at
             baseline as ≥10 mm in the longest diameter (except lymph nodes which must have a
             Revised Clinical Study Protocol short axis ≥15 mm) with computed tomography (CT) or
             magnetic resonance imaging (MRI) and that is suitable for accurate repeated
             measurements as per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST
             1.1) guidelines.

          6. Age >18 years at time of study entry.

          7. World Health Organisation (WHO) performance status of 0 or 1.

          8. Body weight >30kg.

          9. Adequate normal organ and marrow function as defined below:

               1. Haemoglobin ≥9.0 g/dL = 5.6 mmol/L;

               2. Absolute neutrophil count (ANC) ≥1.5 x 109/L;

               3. Platelet count ≥100 x 109/L;

               4. Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). (Does not apply
                  to patients with confirmed Gilbert's syndrome, who will be allowed only in
                  consultation with the treating physician);

               5. AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver
                  metastases are present, in which case it must be ≤5x ULN;

               6. Measured creatinine clearance (CL) >30 mL/min or Calculated creatinine clearance
                  CL>30 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by
                  24-hour urine collection for determination of creatinine clearance:

             Males:

             Creatinine CL (mL/min) = Weight (kg) x (140 - Age) 72 x serum creatinine (mg/dL)

             Females:

             Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine
             (mg/dL)

         10. Evidence of post-menopausal status or negative urinary or serum pregnancy test for
             female pre-menopausal patients. Women will be considered post-menopausal in case of
             amenorrhoeu for 12 months without an alternative medical cause. The following
             age-specific requirements apply:

               -  Women <50 years of age would be considered post-menopausal in case of amenorrhea
                  for 12 months or more following cessation of exogenous hormonal treatments and
                  with luteinizing hormone and follicle-stimulating hormone levels in the
                  post-menopausal range for the institution or underwent surgical sterilization
                  (bilateral oophorectomy or hysterectomy);

               -  Women ≥50 years of age would be considered post-menopausal in case of amenorrhea
                  for 12 months or more following cessation of all exogenous hormonal treatments,
                  had radiation-induced menopause with last menses >1 year ago, had
                  chemotherapy-induced menopause with last menses >1 year ago, or underwent
                  surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or
                  hysterectomy);

         11. Patient is willing and able to comply with the protocol for the duration of the study
             including undergoing treatment and scheduled visits and examinations including follow
             up.

         12. Must have a life expectancy of at least 12 weeks

        Exclusion Criteria:

        Patients should not enter the study if any of the following exclusion criteria are
        fulfilled:

          1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
             staff and/or staff at the study site).

          2. Participation in another clinical study with an investigational product during the
             last 4 weeks.

          3. Concurrent enrollment in another clinical study, unless it is an observational
             (non-interventional) clinical study or during the follow-up period of an
             interventional study.

          4. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine
             therapy, targeted therapy, biologic therapy, tumour embolization, monoclonal
             antibodies) ≤28 days prior to the first dose of study drug.

          5. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the
             exception of alopecia, vitiligo, and the laboratory values defined in the inclusion
             criteria

               -  Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after
                  consultation with the Study Physician;

               -  Patients with irreversible toxicity not reasonably expected to be exacerbated by
                  treatment with durvalumab or tremelimumab may be included only after consultation
                  with the Study Physician;

               -  Toxicity caused by treatment with anti-PD(L)1 should return to baseline, except
                  for endocrine toxicity on a stable dose of replacement therapy.

          6. Any concurrent chemotherapy, investigational product (IP), biologic, or hormonal
             therapy for cancer treatment. Concurrent use of hormonal therapy for
             non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.

          7. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of
             radiation within 4 weeks of the first dose of study drug.

          8. Major surgical procedure (as defined by the Investigator) within 28 days prior to the
             first dose of IP. Note: Local surgery of isolated lesions for palliative intent is
             acceptable.

          9. History of allogenic organ transplantation.

         10. Active or prior documented autoimmune or inflammatory disorders (including
             inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with
             the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome,
             or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid
             arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this
             criterion:

               -  Patients with vitiligo or alopecia;

               -  Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on
                  hormone replacement;

               -  Any chronic skin condition that does not require systemic therapy. Psoriasis, if
                  not treated by immunesuppressants, is allowed;

               -  Patients without active disease in the last 5 years may be included but only
                  after consultation with the study physician;

               -  Patients with celiac disease controlled by diet alone.

         11. Uncontrolled intercurrent illness, including but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
             angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic
             gastrointestinal conditions associated with diarrhea, or psychiatric illness/social
             situations that would limit compliance with study requirement, substantially increase
             risk of incurring AEs or compromise the ability of the patient to give written
             informed consent.

         12. History of another primary malignancy except for:

               -  Malignancy treated with curative intent and with no known active disease ≥2 years
                  before the first dose of IP and of low potential risk for recurrence;

               -  Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
                  of disease;

               -  Adequately treated carcinoma in situ without evidence of disease;

               -  Curatively treated localized prostate cancer without PSA recurrence.

         13. History of leptomeningeal carcinomatosis.

         14. Brain metastases or spinal cord compression, unless radiographically stable, defined
             as 2 brain images, both of which are obtained after treatment to the brain metastases.
             These imaging scans should both be obtained at least four weeks apart and show no
             evidence of intracranial progression. In addition, any neurologic symptoms that
             developed either as a result of the brain metastases or treatment thereof must have
             resolved or be stable either, without the use of steroids, or are stable on a steroid
             dose of ≤10mg/day of prednisone or its equivalent for at least 14 days prior to the
             start of treatment.. Patients with suspected brain metastases at screening should have
             an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study
             entry.

         15. History of active primary immunodeficiency.

         16. Active infection including tuberculosis (clinical evaluation that includes clinical
             history, physical examination and radiographic findings), hepatitis B (known positive
             HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus
             (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined
             as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are
             eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if
             polymerase chain reaction is negative for HCV RNA.

         17. Current or prior use of immunosuppressive medication within 14 days before the first
             dose of durvalumab or tremelimumab. The following are exceptions to this criterion:

               -  Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra
                  articular injection);

               -  Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of
                  prednisone or its equivalent;

               -  Steroids as premedication for hypersensitivity reactions (e.g., CT scan
                  premedication).

         18. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note:
             Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to
             30 days after the last dose of IP.

         19. Female patients who are pregnant or breastfeeding or male or female patients of
             reproductive potential who are not willing to employ effective birth control from
             screening to 180 days after the last dose of tremelimumab, durvalumab, or durvalumab +
             tremelimumab combination therapy.

         20. Known allergy or hypersensitivity to any of the study drugs or any of the study drug
             excipients.

         21. Prior randomisation or treatment in a previous durvalumab and/or tremelimumab clinical
             study regardless of treatment arm assignment.

         22. Previous treatment with anti-CTLA-4 immunotherapy.

         23. Known allergy or hypersensitivity to IP or any excipient. Procedures for withdrawal of
             incorrectly enrolled patients are presented in Section 4.3 of the clinical protocol.
             If a patient withdraws from participation in the study, then that specific
             enrollment/randomization code cannot be reused. Withdrawn patients will not be
             replaced.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michiel MS van der Heijden, MD, PhD, +31 20 512, [email protected]

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT03871036

Organization ID

M18ICR/ESR-18-13667


Responsible Party

Sponsor

Study Sponsor

The Netherlands Cancer Institute

Collaborators

 AstraZeneca

Study Sponsor

Michiel MS van der Heijden, MD, PhD, Principal Investigator, NKI-AvL


Verification Date

March 2021