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Urothelial CarcinomaPhase 2ABLENCT03240016

Abraxane With Anti-PD1/PDL1 in Patients With Advanced Urothelial Cancer

A Phase 2 study testing Pembrolizumab and Abraxane in people with Urothelial Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase 2, single arm, two-stage study of abraxane with an anti-PD1/PDL1 (pembrolizumab) in cisplatin-ineligible patients with advanced urothelial cancer. Each cycle last 21-days. All subjects will receive pembrolizumab via IV on day 1, and abraxane via IV on Day 1 and Day 8 of each cycle. 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?
Pembrolizumab and Abraxane
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
8 Feb 2018to 23 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

  • Patients with recurrent unresectable locally advanced or metastatic urothelial carcinoma (aka transitional cell carcinoma).
  • Patients may be either cisplatin-ineligible or platinum-refractory.
  • Histological or cytologically proven urothelial carcinoma.
  • Have measurable disease based on RECIST 1.1
  • Has urothelial cancer that is not suitable for local therapy administered with curative intent if not already administered.
  • Must have recovered (i.e., AE <= Grade 1 or stable) from AEs due to a previously administered agent.
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  • ECOG Performance Status of 0, 1 or 2. (Eastern Cooperative Oncology Group Performance Status: an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death.)
  • Prior neoadjuvant or adjuvant systemic therapy or local intravesical chemotherapy or immunotherapy is permitted.
  • Adequate organ and marrow function
  • Women of child-bearing potential must either commit to true abstinence or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting IP therapy, and while on study medication or for a longer period if required by local regulations following the last dose of IP; and have a negative serum pregnancy test result at screening
  • Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following drug discontinuation, even if he has undergone a successful vasectomy.
  • Patients must have < Grade 2 pre-existing peripheral neuropathy
  • Be ≥18 years of age as of date of signing informed consent
  • Voluntarily agree to participate by providing written informed consent/assent for the trial

Who cannot join

  • Prior exposure to immune-mediated therapy
  • History of allogenic organ transplantation that requires ongoing use of immunosuppressive agents is NOT permitted
  • Active or prior documented autoimmune or inflammatory disorders are NOT permitted
  • Current or prior use of immunosuppressive medication(s) within 14 days before study treatment is NOT permitted.
  • Brain metastases or spinal cord compression are NOT permitted unless they have been treated with the patient's condition being stable clinically and radiologically for 28 calendar days and off steroids for at least 14 days prior to the start of study treatment.
  • Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) is NOT permitted.
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  • Receipt of live attenuated vaccine within 30 days prior to the first study treatment is NOT permitted.
  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 28 calendar days of the first dose of treatment.
  • CTCAE Grade > 1 peripheral neuropathy is NOT permitted
  • If subjects received major surgery they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting trial therapy
  • Has a known additional malignancy that is progressing or requires active treatment
  • Has a history of severe hypersensitivity reaction to nab-paclitaxel or anti-PD1/PDL1
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Pregnancies:
  • Females: nab-paclitaxel can cause harm to an unborn child if given to a pregnant woman. Females may not take part in this study if pregnant or breast-feeding for 6 months after last dose of study drug.
  • Males: Male subjects should avoid fathering a child while receiving study medication and for 6 months after the last dose of study medication. Males must agree to complete abstinence from heterosexual contact or use a condom during sexual contact with a female of child bearing potential while receiving study medication and within 6 months after last dose of study medication.
  • Subjects (both males and female) should practice effective contraception during study and for 6 months after the last dose of study medication (Section 3.1.8 i, ii).
  • Patients with biliary obstruction or biliary stent are excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: ABLE: Phase II, Single Arm, Two-stage Study of Abraxane With Anti-PD1/PDL1 in Patients With Advanced Urothelial Cancer

This is a phase 2, single arm, two-stage study of abraxane with an anti-PD1/PDL1 (pembrolizumab) in cisplatin-ineligible patients with advanced urothelial cancer.

Each cycle last 21-days. All subjects will receive pembrolizumab via IV on day 1, and abraxane via IV on Day 1 and Day 8 of each cycle. Subjects may continue to receive the study regimen until they experience disease progression or unacceptable toxicity.

Being tested
Pembrolizumab, Abraxane
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.

Study groups in NCT03240016
Study groupRoleWhat they receive
Pembrolizumab and AbraxaneExperimentalPembrolizumab 200mg IV D1 Abraxane 100mg/m^2 IV D1 and D8 21 Day Cycles
Receives: Drug: Pembrolizumab; Drug: Abraxane

What is being measured

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

  1. Percentage of Patients That Respond to Treatment

    The Overall Response Rate (ORR) will be the percentage of patients that achieve either complete response (CR) or partial response (PR).

    CR is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.

    PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.

    Measured: 24 months post treatment, an average of 7.5 months

Secondary outcomes (5)

  1. Duration of Response

    The duration of response (DOR) is measured from the time that response (PR or CR) criteria are met until the first date that recurrent or progressive disease is objectively documented.

    CR is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.

    PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.

    Measured: 24 months post treatment

  2. Progression Free Survival Time

    Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death.

    Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.

    Measured: 24 months post treatment

  3. Median Number of Patients Alive at 12 and 24 Months

    Overall survival will be documented as the median number of patients alive at 12 and 24 months.

    Measured: 12 and 24 months post treatment

  4. Median Duration of Therapy

    Measured: from the start of therapy, up to 24 months

  5. Percentage of Patients That Completely Respond to Treatment

    The percentage of patients that achieve complete response to treatment. Complete response is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.

    Measured: 24 months post treatment, an average of 7.5 months

Timeline

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

  1. First posted4 Aug 2017
  2. Study start8 Feb 2018
  3. Primary completion23 Jun 2023
  4. Study completion23 Jun 2023

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03240016
Sponsor's protocol ID
UMCC 2017.077
Other IDs
HUM00135166
Acronym
ABLE
Status last verified
Jan 2025
First submitted
27 Jul 2017
Last updated
16 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Tsung I, Green E, Palmbos P, Sloan Z, Reichert ZR, Vaishampayan U, Smith DC, Caram MEV, Yentz S, Daignault-Newton S, Hurley L, Nguyen CB, Kraft S, Alva A. A Phase 2 Trial of Nab-paclitaxel in Combination With Anti-PD1 Therapy in Advanced Urothelial Cancer. J Urol. 2023 Jan;209(1):121-130. doi: 10.1097/JU.0000000000002969. Epub 2022 Nov 1.

    PubMed 36317715

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab and Abraxane in people with Urothelial Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site 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 14 inclusion and 19 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 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 16 Jan 2025). 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?

Percentage of Patients That Respond to Treatment (time frame: 24 months post treatment, an average of 7.5 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 NCT03240016, 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 16 Jan 2025.

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