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Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer

ConditionRenal Pelvis and Ureter Urothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

STEP 1 REGISTRATION AND RANDOMIZATION

Patients must be >= 18 years of age

Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible

Biopsy (gold standard, preferred) and either upper urinary tract mass on cross-sectional imaging or tumor directly visualized during upper urinary tract endoscopy

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biopsy Procedure

    Procedure/Surgery

    Undergo tissue biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Cisplatin

    Drug

    Given IV

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Doxorubicin Hydrochloride

    Drug

    Given Iv

  • Durvalumab

    Biological/Vaccine

    Given IV

  • Gemcitabine Hydrochloride

    Drug

    Given IV

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Methotrexate

    Drug

    Given IV

  • Pegfilgrastim

    Biological/Vaccine

    Given via injection

  • Therapeutic Conventional Surgery

    Procedure/Surgery

    Undergo surgery

  • Vinblastine Sulfate

    Drug

    Given Iv

Treatment groups

131 Participants
are divided into 3 treatment groups
Group A: Arm A (durvalumab, chemotherapy)Experimental treatment 11 interventions
Group B: Arm B (chemotherapy)Active comparator 10 interventions
Group C: Arm C (durvalumab, gemcitabine hydrochloride)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Event-free survival (EFS) (Cisplatin eligible cohort: Arms A and B)

Disease progression prior to surgery or omission of surgery due to unresectable tumors, muscle-invasive cancer or disease recurring outside of the bladder, urethra, or contralateral upper tract are considered as events for EFS.

Time frame
From registration/randomization to the earliest of systemic recurrence outside urinary tract, cancer progression, or death from any cause, assessed up to 5 years
2

Pathologic complete response (pCR) (Cisplatin ineligible cohort: Arm C)

Will assess pathologic complete response at surgery (pCR, pT0N0/Nx) by local pathology review. Patients who drop out prior to surgery or who have unknown response status will be considered as non-responders.

Time frame
At surgery

Secondary outcomes

1

pCR (Cisplatin-eligible cohort: Arms A and B)

Time frame
Up to 5 years
2

EFS (cisplatin-ineligible cohort: Arm C)

Will be characterized using the Kaplan-Meier method.

Time frame
From registration/randomization to the earliest of systemic recurrence outside urinary tract, cancer progression, or death from any cause, assessed up to 5 years
3

Overall survival (OS) (All Patients)

OS will be evaluated by arm, post chemotherapy response (ypCR, stage yp =\< T1N0, yp \>= T2N0), as well as stage (ypCR and \> ypCR) within and across treatment arms. Will be estimated using Kaplan-Meier method.

Time frame
From registration/randomization to death from any cause, assessed up to 5 years
4

Urothelial cancer-free survival or disease-free survival (All Patients)

A return of UTUC includes non-muscle invasive recurrences, pathologic T2 or higher muscle-invasive recurrences specifically in the urinary tract, metastatic disease outside the urinary tract, or death. Patients alive without documented UTUC will be censored at the date of last disease assessment.

Time frame
From the date of surgery to the earlier of a return of upper tract urothelial cancer (UTUC) or death from any cause, assessed up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov
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