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Advanced Urothelial CarcinomaPhase 1/2NCT07793578

Immunotherapy Plus Capivasertib for Metastatic Bladder Cancer

A Phase 1/2 study testing capivasertib in people with Advanced Urothelial Carcinoma, run by VA Office of Research and Development at 4 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to determine whether adding an oral medication called Capivasertib to ongoing immunotherapy can enhance treatment responses in patients with advanced bladder cancer (aBC), as well as to evaluate the safety of this combination. Capivasertib is an anti-cancer drug approved by the U.S. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Urothelial Carcinoma
What is being tested?
capivasertib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
4 sitesUnited States
Study dates
1 Jan 2027to 30 Sep 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • Male or female patients are eligible
  • Diagnosis of urothelial carcinoma, with mixed histology permitted:
  • Histologically or cytologically confirmed advanced or recurrent urothelial carcinoma, OR
  • Documented Stage IV disease (T4b, Any N, M0; any T, Any N, M1a-b), Stage IIIB (T1-T4a, N2-N3, M0), or a subset of Stage IIIA (T1-T4a, N1, M0)
  • Genomic testing, including assessment for PIK3CA, AKT1, or PTEN alterations, must have been performed
  • Patients must have stable disease or cancer progression after at least 12 weeks of Immune Checkpoint Inhibitors (ICI) or ICI-based therapy, per RECIST v1.1 guidelines
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  • Patients must have received prior enfortumab vedotin unless contraindicated
  • Patients must be asymptomatic or minimally symptomatic from metastatic urothelial cancer
  • Willingness to receive ICI in combination with capivasertib during the study is required. If cancer progressed on an ICI plus another anti-cancer drug(s) (e.g., pembrolizumab plus enfortumab vedotin), the additional drug(s) must be discontinued for at least 14 days, while ICI is continued, prior to starting capivasertib.
  • Patients must have no or only minimal and stable adverse events from prior cancer-directed therapy, including ICI
  • Measurable disease is required:
  • X-rays, CT/MRI, or physical exams must have been performed within 28 days before starting study medications
  • At least one measurable lesion per RECIST 1.1 must be present at baseline (≥10 mm in longest diameter, or lymph nodes with a short axis ≥15 mm, using CT or MRI; previously irradiated lesions are excluded)
  • Tumor samples:
  • Baseline biopsy prior to treatment is strongly recommended, unless it poses excessive risk
  • When biopsied, in addition to FFPE preparation, fresh tissue should be sent to VABHS for single-cell RNA sequencing and T-cell receptor sequencing
  • If baseline biopsy is not feasible, the most recent FFPE tumor tissue block from primary or metastatic sites should be obtained; if the block is unavailable, 15 (minimum 10) unstained slides are acceptable
  • If biopsy is deemed too risky, participation may proceed without new tissue.
  • Estimated life expectancy of at least 3 months
  • ECOG performance status ≤2 OR Karnofsky ≥60%. For the safety lead-in phase, only ECOG PS 0-1 patients will be included
  • Adequate bone marrow function, without recent transfusions or growth factor support (within 14 days prior to first dose):
  • Absolute neutrophil count > 1,000/cubic millimeters (mm³)
  • Hemoglobin ≥ 9.0 grams (g)/deciliter (dL)
  • Platelets > 100,000/mm³
  • Adequate renal function: Estimated creatinine clearance ≥30 milliliter (mL)/minute (Cockcroft-Gault equation, actual weight), with no need for chronic dialysis. No capivasertib dose adjustment required if clearance ≥30 mL/minute
  • Adequate liver function:
  • Total bilirubin ≤1.5 × upper limit of normal value (ULN), or ≤3 × ULN for documented Gilbert's syndrome.
  • AST and ALT ≤2.5 × ULN (or ≤5 × ULN for hepatic metastases).
  • For females of childbearing potential: Negative serum pregnancy test at screening.
  • Male patients able to father children, and females of childbearing potential, must agree to use two highly effective contraceptive methods throughout the study and for at least 16 weeks after the last dose of capivasertib
  • Signed and dated informed consent indicating the patient has been fully informed about the study
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and all other study procedures

Who cannot join

  • Patients who have undergone major surgery within 4 weeks, or major radiation therapy within 2 weeks, prior to starting treatment. Prior palliative radiotherapy is permitted if completed at least 48 hours before study entry
  • Receipt of another investigational agent within the past 4 weeks. Participation in observational studies is allowed
  • Persistent toxicities (CTCAE Grade ≥2) from previous anticancer therapy, except for alopecia. Patients with irreversible toxicity not reasonably expected to be exacerbated by study intervention (as deemed by the investigator, such as hearing loss) may be included.
  • Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow capivasertib, or prior significant bowel resection that may impair adequate absorption, distribution, metabolism, or excretion of capivasertib.
  • Active tuberculosis infection, as determined by clinical evaluation, imaging, or tuberculosis testing per local practice
  • Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor
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  • Known or suspected hypersensitivity to study drugs or any of their components
  • Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to study intervention. Patients with previously treated CNS metastases may be eligible if they have recovered from acute effects of radiation or surgery, discontinued corticosteroids for at least 4 weeks, and are neurologically stable
  • Diagnosis of any other malignancy within the past 3 years, except adequately treated basal or squamous cell skin cancer, other Stage 0 or 1 cancers, or incidental prostate cancer found at cystoprostatectomy
  • Moderate to severe symptoms from metastatic cancer, including moderate to severe pain, impaired organ function, or spinal cord compression
  • Active autoimmune disease likely to worsen with ICI therapy. Patients with vitiligo, psoriasis, or thyroid disorders controlled without immunosuppressive therapy are eligible
  • Known severe hypersensitivity reactions (Grade >3) to monoclonal antibodies, history of anaphylaxis, or uncontrolled asthma
  • History or concurrent condition of interstitial lung disease or severely impaired lung function, as judged by the investigator
  • Any of the following cardiac risks:
  • Mean resting corrected QT interval (QTc) >470 milliseconds (ms) from triplicate ECGs at screening
  • History of QT prolongation due to medication requiring discontinuation
  • Congenital long QT syndrome, family history of long QT, or unexplained sudden cardiac death under age 40 in first-degree relatives
  • Significant arrhythmias (e.g., symptomatic or CTCAE Grade 3 PVCs, bigeminy, trigeminy, ventricular tachycardia), uncontrolled or symptomatic atrial fibrillation, unless well-controlled by medication or device (investigator and cardiologist review recommended)
  • Clinically significant electrolyte abnormalities linked to QTc prolongation: hypokalemia, hypomagnesemia, hypocalcemia
  • Any other condition(s) significantly increasing QTc prolongation risk per investigator judgment
  • History of coronary artery bypass, angioplasty, myocardial infarction, or unstable angina in the prior 3 months
  • Congestive heart failure (NYHA class ≥2)
  • Clinically significant abnormalities of glucose metabolism, including:
  • Type 1 or insulin-dependent type 2 diabetes
  • HbA1c > 8.0%
  • Current or prior use of immunosuppressive medications within 7 days before study start, except: a. Intranasal, inhaled, topical steroids, or local injections (e.g., intra-articular) b. Systemic corticosteroids up to 10 mg/day of prednisone or equivalent c. Steroids as premedication for hypersensitivity (e.g., CT scan premedication)
  • Active bleeding diathesis.
  • Active infection requiring systemic therapy.
  • Positive for HIV infection or known AIDS, due to potential pharmacokinetic interactions with capivasertib.
  • Hepatitis B (positive surface antigen) or hepatitis C (positive HCV RNA if antibody positive).
  • Any other disease, condition, or laboratory abnormality which, in the investigator's opinion, may confound study results, increase the risks of study complications, contraindicate investigational drug use, or interfere with informed consent
  • Vaccination with live, attenuated, or unknown-status vaccines within 4 weeks of first study treatment or during the trial (except inactivated vaccines, e.g., inactivated influenza and COVID-19 vaccines)
  • Pregnancy, breastfeeding, or unwillingness/inability of female patients of childbearing potential and male patients to use two highly effective contraceptive methods throughout the study and for at least 16 weeks after the last dose of capivasertib
  • History of noncompliance with medical regimens
  • Unwillingness or inability to comply with study protocol

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chong-Xian Pan, MD PhD contact

(857) 203-6189

chong-xian.pan@va.gov

Chun Yang, PhD contact

(857) 736-5462

Chun.Yang@va.gov

United States4 sites

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Boston, Massachusetts, 02130-4817

    Colleen Hynes, BS, (857) 720-5501, Colleen.Hynes@va.gov

    Chong-Xian Pan, MD PhD

  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

    Philadelphia, Pennsylvania, 19104-4551

    Yu-Ning Wang, MD, Yu-Ning.Wong@va.gov

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Seattle, Washington, 98108-1532

    Robert B Montgomery, MD, Robert.Montgomery@va.gov

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    West Haven, Connecticut, 06516-2770

    Yu Zhang, MD, Yu.Zhang2@va.gov

Other trials in United States

About this study

Official title: A Phase Ib/Phase II Trial With Capivasertib Plus Immunotherapy in Bladder Cancer

This study aims to determine whether adding an oral medication called Capivasertib to ongoing immunotherapy can enhance treatment responses in patients with advanced bladder cancer (aBC), as well as to evaluate the safety of this combination. Capivasertib is an anti-cancer drug approved by the U.S. Food and Drug Administration (FDA) for breast cancer, but it is not approved for aBC and, in this study, will be used as an investigational agent. Immunotherapy is FDA-approved for aBC, yet while some patients respond, others either do not benefit or develop resistance after an initial response. Previous research indicates that drugs similar to Capivasertib may increase the effectiveness of immunotherapy. Therefore, this study will enroll patients whose aBC no longer responds to immunotherapy, add Capivasertib to their treatment regimen, and monitor for improvements in immune response against aBC and any potential side effects associated with the combination therapy.

Read the detailed description

This study will enroll patients with advanced bladder cancer who have previously received an immune checkpoint inhibitor (ICI) or ICI-based therapy and whose cancer is no longer responding to treatment. In this trial, patients will continue their ICI therapy while capivasertib is added to their regimen. Participants will be closely monitored to assess whether the addition of capivasertib enhances the cancer's response to ICI therapy and to evaluate the safety and potential toxicities of the combination treatment.

Being tested
capivasertib
Keywords
advanced urothelial carcinoma, immune checkpoint inhibitor, PI3K/AKT, capivaseretib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • capivasertibDrug

    Also called Truqap

    Patients will continue their immune checkpoint inhibitor (ICI) treatment, with capivasertib added at a dose of 400 mg orally twice daily, administered on a schedule of 4 days on followed by 3 days off, continuously throughout the study period.

Study groups in NCT07793578
Study groupRoleWhat they receive
treatmentExperimentalPatients will continue immune checkpoint inhibitor (ICI) treatment and capivasertib will be added
Receives: Drug: capivasertib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    ORR is defined as the percentage of patients who have a partial or complete response at any time during the treatment of this trial.

    Measured: through study completion, an average of 1 year

Secondary outcomes (5)

  1. Progression-free survival (PFS)

    PFS is defined as the time between initiation of the ICI/capivasertib combination treatment and tumor progression or death from any cause, with censoring of patients who are lost to follow-up

    Measured: through study completion, an average of 1 year

  2. Overall survival (OS)

    OS is defined as the length of time from the start of this trial treatment to the time of death from any cause, with censoring of patients who are lost to follow-up.

    Measured: through study completion, an average of 1.5 year

  3. Disease control rate (DCR)

    DCR is the percentage of patients who have a partial or complete response or stable disease at any time during this treatment of this trial.

    Measured: through study completion, an average of 1 year

  4. Safety

    Safety will be determined by percentage of patients who develop adverse events (AEs) during the study. AEs will be graded on a 1-5 scale based on the Common Terminology Criteria for Adverse Events (CTCAE).

    Measured: through study completion, an average of 1 year

  5. Tolerability

    Tolerability will be determined based on percentage of patients who have study drug dose reduction or discontinuation during the study secondary of adverse events.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2026
  2. Study start1 Jan 2027 (estimated)
  3. Primary completion30 Sep 2029 (estimated)
  4. Study completion30 Sep 2030 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All patients will continue ICI treatment and capivasertib will be added to the ongoing ICI treatment
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07793578
Sponsor's protocol ID
SPLP-001-25F
Other IDs
VA ORD
Status last verified
Sep 2026
First submitted
19 Aug 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Aggregated data without any identifiable information will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing capivasertib in people with Advanced Urothelial Carcinoma, run by VA Office of Research and Development at 4 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 32 inclusion and 35 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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chong-Xian Pan, MD PhD ((857) 203-6189, chong-xian.pan@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: through study completion, an average of 1 year). 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 NCT07793578.

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 5 Oct 2026.

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