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A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer

ConditionsNon-muscle Invasive Bladder CancerNon-Muscle Invasive Bladder Urothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohn Sfakianos

About this trial

This is a phase 2 open-label two cohort study of durvalumab plus monalizumab in patients with BCG-unresponsive or BCG-exposed CIS NMIBC. Arm A will enroll 43 participants who have cancer in situ (CIS) with or without high grade papillary urothelial cancer. Arm B will enroll 17 participants who do not have cancer in situ (CIS) but do have high grade papillary urothelial cancer. Eligible patients will be enrolled to receive up to 13 cycles of monthly combination of monalizumab and durvalumab. Both monalizumab and durvalumab will be administered intravenously (IV) every 28 days.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years at the time of consent.

Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. Able and willing to provide written informed consent.

Eastern Cooperative Oncology Group scores ≤ 1 within 28 days prior to registration.

Non-muscle-invasive bladder cancer

Disqualifiers

Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).

Prior CIS of the ureters or prostatic urethra within 24 months prior to registration.

Evidence of metastatic disease on imaging (CT or MRI) of the abdomen and pelvis within 90 days of registration.

Body weight ≤ 30 kg.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Durvalumab

    Drug

    Durvalumab 1500mg IV

  • Monalizumab

    Drug

    Monalizumab 1500mg IV

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Cohort A: Durvalumab and Monalizumab for CIS +/- high grade papillary urothelial cancerExperimental treatment 2 interventions
Group B: Cohort B: Durvalumab and Monalizumab for high grade papillary urothelial cancer without CISExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Complete Response

Complete response will be determined by bladder biopsy and urinary cytology for malignancy for subjects with a CIS component at 6 months CT/MRI urography will be used to rule out extravesical disease. (Cohort A)

Time frame
6 months

Secondary outcomes

1

Incidence of treatment related Adverse Events

Safety will be determined by summarizing all treatment related adverse events according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5. (Cohort A and B)

Time frame
12 months
2

Progression-free Survival (PFS)

Progression-free survival (PFS) will be measured from the date of study registration to the date of progression or death due to any cause, whichever occurs first. Surviving patients without any documented progression will be censored at the date of last known contact. Progression will be defined as the development of muscle invasive bladder cancer or metastatic urothelial cancer (nodal and/or distant). (Cohort A)

Time frame
36 months
3

Overall Survival (OS)

Overall survival (OS) will be measured from the date of study registration to date of death due to any cause. Surviving patients will be censored at the date of last known contact. (Cohort A)

Time frame
36 months
4

Event Free Survival

Event-free survival will be measured from the date of study registration to the first documentation of an event. Patients without documented events and who are still alive, will be censored at last disease assessment. Patients who start any subsequent anti- cancer therapy without any reported events will be censored at their last disease assessment. (Cohort A)

Time frame
36 months

Other outcomes

Sponsors and contacts

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

John Sfakianos

Lead sponsor

Hoosier Cancer Research Network

Sponsor institution

AstraZeneca

Collaborator

Icahn School of Medicine at Mount Sinai

Collaborator

Bladder Cancer Advocacy Network

Collaborator

Source ClinicalTrials.gov
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