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Vaccine

Immunotherapy + Chemotherapy for Bladder Cancer (ADAPT-BLADDER Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Noah Hahn, M.D.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate hematologic, hepatic, and renal function as defined by specific laboratory parameters

Age ≥ 18 years old at time of consent

Must not have

Subjects with another active second malignancy other than non-melanoma skin cancers and biochemical relapsed prostate cancer

Subjects with muscle-invasive locally advanced unresectable, or metastatic urothelial carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years (24 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is for a treatment for bladder cancer. It will test different combinations of drugs, some with BCG and some without. If the side effects from a certain combination are too severe, that combination will not be used.

Who is the study for?

Adults with non-muscle invasive bladder cancer confirmed within the last 60 days, who are generally healthy and have good organ function. They must not have other active cancers (except certain skin or prostate cancers), severe medical conditions, or be pregnant/breastfeeding. Participants need to use contraception and agree to follow study rules.

What is being tested?

The trial is testing Durvalumab alone or in combination with treatments like EBRT, Gemcitabine, Docetaxel, Tremelimumab, and BCG for bladder cancer. It starts with Durvalumab; if safe, it adds other treatments. Patients join different groups based on availability and choice of radiation participation.

What are the potential side effects?

Durvalumab can cause immune-related inflammation in organs, infusion reactions similar to allergic responses when receiving the drug through a vein, fatigue, potential liver issues (hepatitis), lung problems (pneumonitis), hormone gland disorders (like thyroid issues), and increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood, liver, and kidney tests are within normal ranges.

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I am 18 years old or older.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have another cancer besides non-melanoma skin cancer or prostate cancer that is not actively growing.

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My bladder cancer cannot be removed by surgery and has spread.

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I am not pregnant, breastfeeding, and if capable of childbearing or fathering children, I am using contraception.

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I do not have any severe or uncontrolled health conditions.

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I haven't taken immunosuppressive drugs in the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years (24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years (24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years (24 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Determine the recommended phase 2 dose (RP2D) from BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)

Phase 2: Determine the complete response rate within individual phase 2 expansion cohorts of BCG-unresponsive, BCG-relapsing/persistent, and high-risk BCG-naïve NMIBC subjects treated with each study regimen

Secondary study objectives

Phase 1: Assess Adverse Events

Phase 1: Characterize the 12-month recurrence free survival (RFS) rate of BCG-unresponsive NMIBC subjects treated with each study regimen

Phase 1: Characterize the complete response rate of BCG-unresponsive NMIBC subjects treated with each study regimen

+3 more

Side effects data

From 2017 Phase 2 trial • 989 Patients • NCT02075203

10%

Injection site pain

Upper respiratory tract infection

Headache

Injection site swelling

Fatigue

Myalgia

Nausea

Injection site erythema

Arthralgia

Injection site warmth

Chills

Blood pressure systolic increased

White blood cell count increased

Pyrexia

Proteinuria

Rash

Diarrhoea

Haemoglobin decreased

Gastritis

Pyelonephritis

Pharyngitis

Lymphadenopathy

Vomiting

Conjunctivitis

Varicella

Neutrophil count increased

Haematuria

Blood pressure increased

Platelet count increased

Dysmenorrhoea

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

AERAS-404 (15 mcgH4/500 Nmol IC31)

Bacillus Calmette-Guerin (BCG)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Group I: Phase 2: Cohort 4 ExpansionExperimental Treatment3 Interventions

Durvalumab + Gemcitabine/Intravesical Docetaxel (Gem/Doc) The sequence of administration is flexible to allow for scheduling of both the infusion and intravesical treatments.

Group II: Phase 1: Cohort 6Experimental Treatment1 Intervention

Additional Regimens (to be determined)

Group III: Phase 1: Cohort 5Experimental Treatment4 Interventions

NOTE: Cohort 5 was abandoned prior to any patients enrolled. Durvalumab + Tremelimumab + Gem/Doc The sequence of administration is flexible to allow for scheduling of both the infusion and intravesical treatments. For the intravenous medications, durvalumab should be administered first followed by tremelimumab.

Group IV: Phase 1: Cohort 4Experimental Treatment3 Interventions

Durvalumab + Gemcitabine/Intravesical Docetaxel (Gem/Doc) The sequence of administration is flexible to allow for scheduling of both the infusion and intravesical treatments.

Group V: Phase 1: Cohort 3Experimental Treatment2 Interventions

Durvalumab plus External Beam Radiotherapy (EBRT) (BCG re-treatment) - Cross-over to Durvalumab Monotherapy

Group VI: Phase 1: Cohort 2Experimental Treatment2 Interventions

Durvalumab plus BCG

Group VII: Phase 1: Cohort 1Experimental Treatment1 Intervention

Durvalumab monotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bacillus Calmette-Guérin (BCG)

2014