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BRIEF TITLE: A Phase II Open Label Single Arm Study of Adjuvant Nivolumab Following Chemo-Radiation in Localized Muscle-Invasive Bladder Cancer (NEXT)

A Phase II Open Label Single Arm Study of Adjuvant Nivolumab Following Chemo-Radiation in Localized Muscle-Invasive Bladder Cancer (NEXT)


  • Org Study ID: HCI100769
  • Secondary ID:
  • NCT ID: NCT03171025
  • NCT Alias:
  • Sponsor: University of Utah - Other
  • Source: University of Utah

Brief Summary

This is a phase 2, single arm, open label trial to evaluate the rate of failure free survival at 2 years after start of study treatment with adjuvant nivolumab in adult subjects who undergo chemoradiation for localized bladder cancer.

Overal Status Start Date Phase Study Type
Recruiting July 10, 2017 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Two-year rate of failure-free survival (FFS)

Primary Outcome 1 - Time Frame: 2 years

Condition:

  • Bladder Cancer

Eligibility

Criteria:
Inclusion Criteria:

- Patients with muscularis propria invasion clinical stages 2 to 4 (T2-4a, N0 or N+, M0
or T1 with N+), who are not candidates for radical cystectomy.

- Patients may have undergone partial cystectomy for removal of bladder tumor prior
to chemoradiation. Patients who have down-staged from M1 disease to M0 with prior
platinum-based chemotherapy will be eligible.

- Staging is determined prior to chemoradiation

- Patients must have histologically proven primary carcinoma of the bladder or urethra
or lower ureter (adenocarcinoma or transitional or squamous-cell carcinoma)

- Tumor tissue from the most recently resected site of disease (preferable) or from the
transurethral resection that yielded the initial muscle invasive diagnosis must be
provided for biomarker correlative analyses. Enrollment is permitted if adequate
archived tissue is unavailable.

- Patients must have received systemic radiosensitizing chemotherapy with definitive
pelvic radiation therapy. Patients may have received partial amount of chemotherapy
and radiation (both) to be eligible.

- Platinum based chemotherapy prior to chemoradiation is permitted but not mandatory

- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2

- Age ≥18.

- Adequate bone marrow function White Blood Cell (WBC) > 2000/µl, neutrophils >1500/µl,
Hemoglobin >9.0 g/dl.

- Serum bilirubin and aminotransferase values less than 1.5 times the upper limit of the
normal range

- Creatinine clearance of 20 ml/min or greater as measured by the Cockroft-Gault formula

- Able to start study treatment within 90 days of completion of chemoradiation.

- Female subject of childbearing potential should have a negative urine or serum
pregnancy within 72 hours prior to receiving the first dose of study medication. If
the urine test is positive or cannot be confirmed as negative, a serum pregnancy test
will be required.

- Female subjects of childbearing potential should be willing to use 2 methods of birth
control or be surgically sterile, or abstain from heterosexual activity for the course
of the study through 7 months after the last dose of study medication. Subjects of
childbearing potential are those who have not been surgically sterilized or have not
been free from menses for > 1 year.

- Male subjects should agree to use an adequate method of contraception starting with
the first dose of study therapy through 7 months after the last dose of study therapy.

- All toxicities attributed to prior anti-cancer therapy other than nephropathy,
neuropathy, hearing loss, alopecia and fatigue must have resolved to Grade 1 (NCI
CTCAE version 4) or baseline before administration of study drug. Subjects with
toxicities attributed to prior anti-cancer therapy which are not expected to resolve
and result in long lasting sequelae, such as neuropathy after platinum based therapy,
are permitted to enroll.

- Able to provide informed consent and willing to sign an approved consent form that
conforms to federal and institutional guidelines.

Exclusion Criteria:

- Evidence of distant metastases or lymph node metastasis (es) that was not within the
radiation field.

- Known additional malignancy that is progressing or requires active treatment.
Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the
skin. A history of localized early stage malignancy that has undergone potentially
curative therapy or is low grade and does not require active treatment is allowed.

- Diffuse bladder carcinoma in situ (CIS) that was not able to be encompassed in a boost
radiotherapy volume

- Patients with inflammatory bowel disease

- Patients with active, known or suspected autoimmune disease. Subjects with vitiligo,
type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only
requiring hormone replacement, psoriasis not requiring systemic treatment, or
conditions not expected to recur in the absence of an external trigger are permitted
to enroll.

- Patients with a condition requiring systemic treatment with either corticosteroids
(>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14
day of study drug administration. Inhaled, ocular, intraarticular, intranasal and
topical steroids are permitted.

- Patients with a known chronic immunocompromised state, HIV infection or active
Hepatitis B or Hepatitis C infection.

- Patients who desire and that are candidates for radical cystectomy

- Pregnancy or women of childbearing potential not willing to use contraception and men
who are sexually active and not willing/able to use medically acceptable forms of
contraception and breast-feeding women not willing to stop breastfeeding during study.

- Severe active co-morbidity as determined by the investigator or principal investigator

- Life expectancy less than 2 years
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Hillary Finch

Phone: 801-213-6126

Email: hillary.finch@hci.utah.edu

Location

Facility Status Contact
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Recruiting Hillary Finch
801-213-6126
hillary.finch@hci.utah.edu