Clinical trial · Interventional
Study of CP-675,206 in Bacillus Calmette-Guerin (BCG)-Resistant Bladder Cancer
Phase I Dose-escalation Trial of CP-675,206 (Tremelimumab, Anti-CTLA-4 Monoclonal Antibody) for Patients With BCG-resistant Localized Transitional Cell Carcinoma of the Bladder
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of accrual
Summary
Brief summary (as posted)
The purpose of this study is to find out the highest safe dose of the investigational drug CP-675,206 when given in combination with BCG therapy to patients who have experienced recurrent superficial bladder cancer after standard BCG treatment. In addition, the study will look to see if taking CP 675,206 generates an immune response and evaluate how the drug affects superficial bladder cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCG and CP-675,206 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 in combination with CP-675,206 I.V. week 3, week 1
- interventionNames
- Drug: BCG and CP-675,206
Primary outcomes (1)
- measure
- To determine the safety of CP-675,206 when delivered in combination with BCG in patients with BCG-resistant bladder carcinoma in situ
- timeFrame
- 24 months
Secondary outcomes (5)
- measure
- To determine whether patients treated with CP-675,206 in combination with BCG develop cancer antigen-specific systemic immune responses
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of transitional cell cancer of the bladder must have completed a transurethral resection of all visible bladder tumors, and have completed two previous 6-week courses with intravesical BCG. * Evidence of disease recurrence within 1 year of previous BCG treatment * Tumor tissue must be available from biopsy for study related immunohistochemical analysis * If sexually active must use reliable form of contraception while on study and for 4 weeks after last treatment * ECOG performance status of \<2 * Life expectancy of at least 6 months * Adequate hematologic, renal and liver function * Informed consent Exclusion Criteria: * No evidence of immunosuppression or treated with immunosuppressive therapy within 6 months * No prior radiation to the pelvis * No gross hematuria within 1 week prior to planned week 1 treatment * Cannot have previous intolerance to BCG * Cannot be seropositive for HIV, hepatitis B(HBV) or hepatitis C(HCV) per patient history * No evidence of metastatic disease * No prior treatment with anti-CTLA-4 monoclonal antibody * Can not be pregnant or lactating * No history of autoimmune disorder * No history of thyroid or adrenal insufficiency * No history of inflammatory bowel conditions, including diverticulitis, ulcerative colitis, Crohn's or celiac disease, intractable urinary tract infection
References
Publications (0)
Data not yet available