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Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer (POTOMAC)

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ClinicalTrials.gov Identifier: NCT03528694
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This is a randomized, open-label, multi-center, global, phase III study to determine the efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with non-muscle-invasive bladder cancer.

Condition or disease Intervention/treatment Phase
Non-muscle-invasive Bladder Cancer Biological: Durvalumab (MEDI4736) Biological: Bacillus Calmette-Guerin (BCG) Phase 3

Detailed Description:
Patients will be randomized in a 1:1:1 ratio to receive treatment with Durvalumab + BCG combination therapies, or Standard of Care (SoC) therapy.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 975 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG Naïve Non-Muscle Invasive Bladder Cancer Patients
Actual Study Start Date : May 14, 2018
Estimated Primary Completion Date : November 24, 2021
Estimated Study Completion Date : November 25, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Durvalumab plus BCG (induction + maintenance)
Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy
Biological: Durvalumab (MEDI4736)
Investigational product

Biological: Bacillus Calmette-Guerin (BCG)
Standard of care

Experimental: Durvalumab plus BCG (induction only)
Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy
Biological: Durvalumab (MEDI4736)
Investigational product

Biological: Bacillus Calmette-Guerin (BCG)
Standard of care

Active Comparator: BCG treatment (Standard of care therapy)
Bacillus Calmette-Guerrin (BCG) standard of care treatment
Biological: Bacillus Calmette-Guerin (BCG)
Standard of care




Primary Outcome Measures :
  1. The efficacy of Durvalumab + BCG (induction plus maintenance) combination therapy compared to SoC in terms of Disease free survival (DFS) in patients with NMIBC [ Time Frame: Up to 4 years ]

Secondary Outcome Measures :
  1. The efficacy of Durvalumab + BCG (induction plus maintenance) therapy compare to SoC in terms of DFS after 24 months of last subject's last dose of IP [ Time Frame: Up to 4 years ]
  2. Disease-related symptoms and HRQoL in patients with NMIBC treated with Durvalumab + BCG combination therapies compared to SoC and compared to each other using the EORTC QLQ-C30 questionnaire [ Time Frame: Up to 4 years ]
    EORTC QLQ-C30 measures cancer patients' functioning (HRQoL) and symptoms for all cancer types and consists of functional, symptom and a global measure of health status scales

  3. Patient-reported treatment tolerability using specific PRO CTCAE symptoms [ Time Frame: Up to 4 years ]
  4. The serum concentration of Durvalumab plus BCG combination therapies [ Time Frame: Up to 4 years ]
  5. The immunogenicity of Durvalumab when used in combination with BCG treatment assessed by descriptive summary of presence of ADAs [ Time Frame: Up to 4 years ]
    Serum will be tested for the presence of anti-drug antibodies.

  6. The efficacy of Durvalumab + BCG (induction plus maintenance) therapy compare to SoC in terms of OS [ Time Frame: Up to 7 years ]
  7. The efficacy of Durvalumab + BCG (induction plus maintenance) combination therapy compared to SoC in terms of time to muscle invasive bladder cancer and/or metastatic disease [ Time Frame: Up to 7 years ]
  8. The efficacy of Durvalumab + BCG (induction only) combination therapy compared to SoC in terms of DFS after 24 months of last subject's last dose of IP [ Time Frame: Up to 4 years ]
  9. The efficacy of Durvalumab + BCG combination therapies compared to each other in terms of DFS after 24 months of last subject's last dose of IP [ Time Frame: Up to 4 years ]
  10. The efficacy of Durvalumab + BCG (induction only) combination therapy compared to SoC in terms of OS [ Time Frame: Up to 7 years ]
  11. The efficacy of Durvalumab + BCG combination therapies compared to each other in terms of OS [ Time Frame: Up to 7 years ]
  12. The efficacy of Durvalumab + BCG (induction only) combination therapy compared to SoC in terms of time to muscle invasive bladder cancer and/or metastatic disease [ Time Frame: Up to 7 years ]
  13. The efficacy of Durvalumab + BCG combination therapies compared to each other in terms of time to muscle invasive bladder cancer and/or metastatic disease [ Time Frame: Up to 7 years ]
  14. Disease-related symptoms and HRQoL in patients with NMIBC treated with Durvalumab + BCG combination therapies compared to SoC and compared to each other using the the EORTC QLQ NMIBC24 questionnaire [ Time Frame: Up to 4 years ]
    EORTC QLQ-NMIBC24 assesses disease-specific symptoms of patients with intermediate to high-risk NMIBC.


Other Outcome Measures:
  1. Number of treatment-related adverse events as assessed by CTCAE v4.0 in patients receiving Durvalumab + BCG combination therapies compared to SoC [ Time Frame: Up to 4 years ]
    The safety and tolerability profile of Durvalumab + BCG combination therapies compared to SoC using vital signs, laboratory data, electrocardiograms (ECGs), and adverse event data.



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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  • Aged at least 18 years
  • BCG-naïve patients.
  • Documented evidence of high-risk transitional cell bladder carcinoma stages T1 tumor, High grade/G3 tumor, CIS, or multiple and recurrent and large (with diameter of largest evaluable node ≥3 cm) tumors (all conditions must be met in this point)
  • Complete resection of all Ta/T1 papillary disease.
  • No prior radiotherapy to the bladder.
  • No prior exposure to immune-mediated therapy of cancer.

Exclusion Criteria:

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

  • Evidence of muscle-invasive, locally advanced, metastatic, and/or extra vesical bladder cancer (ie, T2, T3, T4, and / or stage IV).
  • Concurrent extravesical (ie, urethra, ureter, or renal pelvis), non-muscle-invasive transitional cell carcinoma of the urothelium.
  • Previous investigational product (IP) assignment in the present study
  • Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
  • Active or prior documented autoimmune or inflammatory disorders (eg, colitis, Crohn's disease, Graves' disease, rheumatoid arthritis etc.)
  • History of another primary malignancy
  • Active infection including TB, HBV, HCV and HIVActive infection.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528694


Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

  Show 101 Study Locations
Sponsors and Collaborators
AstraZeneca

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03528694     History of Changes
Other Study ID Numbers: D419JC00001
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by AstraZeneca:
Durvalumab
BCG
MEDI4736
NMIBC
PD-L1
DFS
OS

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Antibodies, Monoclonal
BCG Vaccine
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic