Urothelial CarcinomaPhase 2NCT03557918
Trial of Tremelimumab in Patients With Previously Treated Metastatic Urothelial Cancer
A Phase 2 study testing Tremelimumab in people with Urothelial Carcinoma, run by Matthew Galsky at 7 sites in United States.
Trial summary
This is a phase II trial designed to estimate the activity of single agent tremelimumab in subjects with metastatic urothelial cancer with disease progression despite prior treatment with PD-1/PD-L1 blockade. The primary endpoint is objective response rate and the study will employ a Simon's 2-stage design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Tremelimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 7 sitesUnited States
- Study dates
- 12 Nov 2018to 7 Jun 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- ECOG Performance Status of 0 or 1 within 14 days prior to registration.
- Histologically or cytologically documented urothelial cancer. Locally advanced (T4b, any N; or any T, N 2-3) or metastatic disease (M1, Stage IV) (also termed TCC or UCC of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra). Subjects with mixed histologies are eligible provided that the predominant component is urothelial cancer. Locally advanced bladder cancer must be inoperable on the basis of involvement of pelvic sidewall or adjacent viscera (clinical Stage T4b) or bulky nodal metastasis (N2-N3).
- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks preferred) or at least 15 unstained slides. If archival tissue is not available and the subject is undergoing a standard of care biopsy, tissue from the biopsy is required to be submitted for correlative analyses. Subjects without adequate baseline tumor tissue may be considered for enrollment on a case by case basis after discussion with the sponsor-investigator.
- Measurable disease according to RECIST 1.1 within 28 days prior to registration. 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 short axis ≥15 mm) with computed tomography (CT) (preferred) or magnetic resonance imaging (MRI) scans, preferably with IV contrast, and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines; lesions in a previously irradiated field can be used as a measurable disease provided that there has been demonstrated progression in the lesion.
- A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study registration, have been off of corticosteroids for ≥ 2 weeks, and are asymptomatic
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- Subjects must have progressed despite prior treatment with anti-PD-1/PD-L1 antibody therapy. In addition, subjects must meet the following criteria:
- Subjects must not have progressed within 2 months of starting prior anti-PD-1/PD-L1 antibody therapy.
- Subjects must have received at least 1 line of prior systemic therapy
- Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
- All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study with the exception of endocrine related AEs that are stable on replacement therapy (e.g., steroids, thyroid hormone) which may be considered eligible but must be discussed with the sponsor-investigator.
- Must not have experienced a ≥ Grade 3 immune related AE or an immune related neurologic (neuro-muscular) or ocular AE of any grade while receiving prior immunotherapy. NOTE: Subjects with endocrine AE of ≤ Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic. 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.
- Patients with Gr 3 AST/ALT elevation < 8 fold that resolved with steroids without additional immunosuppression can be included (Patients who experienced Hy's law on PD-1/L1 therapy will be excluded)
- Prior cancer treatment must be completed at least 28 days or 5 half-lives (whichever is shorter) prior to first dose of study drug. Subjects must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤ Grade 1 or baseline.
- Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 14 days prior to registration.
- Absolute Neutrophil Count (ANC) ≥ 1500/mm3
- Hemoglobin (Hgb) ≥ 9 g/dL
- Renal
- Calculated creatinine clearance ≥ 30 cc/min OR
- Creatinine ≤ 1.5
- Bilirubin ≤ 1.5 × upper limit of normal (ULN); This will not apply to
- Aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 x ULN for subjects with hepatic metastases
- Alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 x ULN for subjects with hepatic metastases
- Evidence of postmenopausal status or negative urinary or serum pregnancy test for female premenopausal subjects. Women will be considered postmenopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- Females of childbearing potential who are sexually active with a non-sterilized male partner must be willing to abstain from heterosexual activity or to use 1 highly of effective method of contraception from the time of informed consent until 90 days after the last dose of tremelimumab. Non-sterilized male partners of a female patient must use male condom plus spermicide throughout this period. See Table 2 for acceptable contraceptive methods.
- Non-sterilized males who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from screening through 90 days after receipt of the final dose of tremelimumab. Female partners (of childbearing potential) of male subjects must also use a highly effective method of contraception throughout this period
Who cannot join
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Known additional malignancy that is active and/or progressive requiring treatment. Patients with incidental histologic findings of prostate cancer (tumor/node/metastasis stage of T1a or T1b or prostate-specific antigen <10) who have not received hormonal treatment may be included, pending a discussion with the sponsor-investigator
- Treatment with any investigational drug within 28 days prior to registration.
- Prior treatment with an anti-CTLA-4 antibody
- Any unresolved toxicity National Cancer Institute (NCI) CTCAE Version 4.03 Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and laboratory values defined in the inclusion criteria.
- Subjects with Grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Sponsor Investigator
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- Subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with tremelimumab (e.g., hearing loss) may be included after consultation with the sponsor-investigator
- Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer related conditions (e.g., hormone replacement therapy) is acceptable. Note: Local treatment of isolated lesions, excluding target lesions, for palliative intent is acceptable (e.g., local surgery or radiotherapy)
- Radiation therapy within 14 days of first dose of study drug
- Major surgical procedure within 28 days prior to first dose of study treatment
- History of allogeneic organ transplantation that requires use of immunosuppressive agents
- Active or prior documented autoimmune of inflammatory disorders (including but not limited to inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome [granulomatosis with polyangiitis], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc). The following are exceptions to this criterion:
- Subjects with vitiligo
- Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Subjects without active disease in the last5 years may be considered for enrollment after discussion with the sponsor-investigator
- Subjects with celiac disease controlled by diet alone may be considered for enrollment after discussion with the sponsor-investigator
- QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated. Any clinically significant abnormalities detected require triplicate ECG results and a mean QTcF <470 ms calculated from 3 ECGs obtained over a brief period (eg, 30 minutes)
- Past medical history of Interstitial Lung Disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
- History of active primary immunodeficiency
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Dana Farber- Partners Cancer Care, Inc
Boston, Massachusetts, 02215
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Ichan School of Medicine at Mount Sinai
New York, New York, 10029-6542
Huntsman Cancer Institute University of Utah
Salt Lake City, Utah, 84112
Georgetown University
Washington D.C., District of Columbia, 20057
University of Kansas Medical Center Research Institute, Inc.
Westwood, Kansas, 66205
About this study
Official title: Phase 2 Trial of Tremelimumab in Patients With Metastatic Urothelial Cancer Previously Treated With PD-1/PD-L1 Blockade
This is a phase II trial designed to estimate the activity of single agent tremelimumab in subjects with metastatic urothelial cancer with disease progression despite prior treatment with PD-1/PD-L1 blockade. The primary endpoint is objective response rate and the study will employ a Simon's 2-stage design.
- Conditions
- Urothelial Carcinoma
- Being tested
- Tremelimumab
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TremelimumabDrug
Tremelimumab 750 mg IV on Day 1 of each 28 day cycle; up to 7 cycles.
Subjects that complete all initial 7 cycles but later progress during follow up may receive an additional 7 cycles of tremelimumab providing they meet eligibility criteria.
| Study group | Role | What they receive |
|---|---|---|
| Tremelimumab | Experimental | Tremelimumab 750 mg IV Day 1 of each 28 day cycle. Up to 7 cycles. Receives: Drug: Tremelimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD.
ORR is defined as the proportion of all subjects with confirmed PR or CR according to RECIST 1.1.
Measured: Up to a maximum of 12 months
Secondary outcomes (5)
Adverse Events
Number of participants with adverse events are reported according to the National Cancer Institute's Common Terminology Criteria for Adverse Events(CTCAE) version 4.
Measured: AE had been recorded from time of consent until 30 days after discontinuation of study drug or until a new anti-cancer treatment starts, whichever occurs first; up to a maximum of 13 months
Disease Control Rate
The disease control rate is defined as the percentage of patients who have achieved complete response, partial response and stable disease by RECIST 1.1
Measured: Up to a maximum of 12 months
Duration of Response
Duration of response (DoR) is defined as the time from randomization to disease progression or death in patients who achieve complete or partial response.
Measured: Up to a maximum of 24 months
Progression Free Survival (PFS)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD.
PFS is defined as time from registration until disease progression met by RECIST 1.1 or death from any cause.
Measured: Time of treatment start until the criteria for disease progression or death. Up to a maximum of 24 months.
Overall Survival
Overall survival is defined as the time from treatment start until death or date of last contact.
Measured: Time of treatment start until death or date of last contact, up to a maximum of 42 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start12 Nov 2018
- Primary completion6 Dec 2021
- Study completion7 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew Galsky
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Matthew Galsky, Hoosier Cancer Research Network
- Investigators
- Matthew D Galsky, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557918
- Sponsor's protocol ID
- HCRN GU17-294
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2018
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miller EJ, Rose TL, Maughan BL, Milowsky MI, Bilen MA, Carthon BC, Gao X, Rapisuwon S, Zhao Q, Yu M, Agarwal N, Galsky MD. Phase 2 trial of tremelimumab in patients with metastatic urothelial cancer previously treated with programmed death 1/programmed death ligand 1 blockade. Cancer. 2024 May 1;130(9):1642-1649. doi: 10.1002/cncr.35179. Epub 2024 Jan 5.
PubMed 38180804
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of Tremelimumab in Patients With Metastatic Urothelial Cancer Previously Treated With PD-1/PD-L1 Blockade
- ClinicalTrials.gov ID
- NCT03557918
- Acronym / sponsor ID
- HCRN GU17-294
- Conditions
- Urothelial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Matthew GalskyUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Posted 3 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II trial designed to estimate the activity of single agent tremelimumab in subjects with metastatic urothelial cancer with disease progression despite prior treatment with PD-1/PD-L1 blockade. The primary endpoint is objective response rate and the study will employ a Simon's 2-stage design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment
| Arm | Type | Receives |
|---|---|---|
| Tremelimumab | Experimental | Drug: TremelimumabTremelimumab 750 mg IV Day 1 of each 28 day cycle. Up to 7 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- ECOG Performance Status of 0 or 1 within 14 days prior to registration.
- Histologically or cytologically documented urothelial cancer. Locally advanced (T4b, any N; or any T, N 2-3) or metastatic disease (M1, Stage IV) (also termed TCC or UCC of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra). Subjects with mixed histologies are eligible provided that the predominant component is urothelial cancer. Locally advanced bladder cancer must be inoperable on the basis of involvement of pelvic sidewall or adjacent viscera (clinical Stage T4b) or bulky nodal metastasis (N2-N3).
- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks preferred) or at least 15 unstained slides. If archival tissue is not available and the subject is undergoing a standard of care biopsy, tissue from the biopsy is required to be submitted for correlative analyses. Subjects without adequate baseline tumor tissue may be considered for enrollment on a case by case basis after discussion with the sponsor-investigator.
- Measurable disease according to RECIST 1.1 within 28 days prior to registration. 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 short axis ≥15 mm) with computed tomography (CT) (preferred) or magnetic resonance imaging (MRI) scans, preferably with IV contrast, and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines; lesions in a previously irradiated field can be used as a measurable disease provided that there has been demonstrated progression in the lesion.
Key exclusion criteria (20 listed)
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Known additional malignancy that is active and/or progressive requiring treatment. Patients with incidental histologic findings of prostate cancer (tumor/node/metastasis stage of T1a or T1b or prostate-specific antigen <10) who have not received hormonal treatment may be included, pending a discussion with the sponsor-investigator
- Treatment with any investigational drug within 28 days prior to registration.
- Prior treatment with an anti-CTLA-4 antibody
- Any unresolved toxicity National Cancer Institute (NCI) CTCAE Version 4.03 Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and laboratory values defined in the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TremelimumabTremelimumab 750 mg IV on Day 1 of each 28 day cycle; up to 7 cycles. Subjects that complete all initial 7 cycles but later progress during follow up may receive an additional 7 cycles of tremelimumab providing they meet eligibility criteria. | Drug | Tremelimumab |
Primary outcome
Objective Response Rate
Time frame: Up to a maximum of 12 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. ORR is defined as the proportion of all subjects with confirmed PR or CR according to RECIST 1.1.
5 secondary outcomes
Adverse Events
Time frame: AE had been recorded from time of consent until 30 days after discontinuation of study drug or until a new anti-cancer treatment starts, whichever occurs first; up to a maximum of 13 months
Disease Control Rate
Time frame: Up to a maximum of 12 months
Duration of Response
Time frame: Up to a maximum of 24 months
Progression Free Survival (PFS)
Time frame: Time of treatment start until the criteria for disease progression or death. Up to a maximum of 24 months.
Overall Survival
Time frame: Time of treatment start until death or date of last contact, up to a maximum of 42 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38180804Miller EJ, Rose TL, Maughan BL, Milowsky MI, Bilen MA, Carthon BC, Gao X, Rapisuwon S, Zhao Q, Yu M, Agarwal N, Galsky MD. Phase 2 trial of tremelimumab in patients with metastatic urothelial cancer previously treated with programmed death 1/programmed death ligand 1 blockade. Cancer. 2024 May 1;130(9):1642-1649. doi: 10.1002/cncr.35179. Epub 2024 Jan 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew D Galsky, MD principal investigator
Icahn School of Medicine at Mount Sinai
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tremelimumab in people with Urothelial Carcinoma, run by Matthew Galsky at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Up to a maximum of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03557918, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.