West Cancer Center

BLADDER: ADJUVANT: IMMUNOTHERAPY BASED ON MRD: ALLIANCE MODERN

MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer

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Malignancy

Bladder cancer, urothelial cancer

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

Nivolumab and relatlimab

Drug Class

PD-1 agent and LAG3 agent

Brad Somer, MD

Sponsor

Alliance for Clinical Trials in Oncology

Path

Urothelial carcinoma

Key Eligibility Criteria Details

Histologically confirmed muscle-invasive urothelial carcinoma of the bladder. Variant histology, including neuroendocrine differentiation, is allowed if urothelial cancer is predominant histology (any amount of squamous differentiation is allowed provided the tumor is not a pure squamous cell cancer)
Patient must have had radical cystectomy and lymph node dissection >= 3 weeks, but =< 12 weeks prior to pre-registration. Patients who have had a partial cystectomy as definitive therapy are not eligible
No gross cancer at the surgical margins. Microscopic invasive urothelial carcinoma at the surgical margins (i.e., "positive margins") are allowed. Carcinoma in situ (CIS) at margins is considered negative margins
No evidence of residual cancer or metastasis after cystectomy
Have undergone a radical cystectomy with pathological evidence of urothelial carcinoma of the bladder at high risk of recurrence as described in one of the two scenarios below (i or ii).
- (i) Patients who have not received neoadjuvant cisplatin-based chemotherapy: pT3-pT4* or pT0/x-pT4/N+ on cystectomy and are not eligible for adjuvant cisplatin chemotherapy
  - (i) Patients ineligible for cisplatin due to at least one of the following criteria and reason for ineligibility should be documented:
    - (i) Creatinine Clearance (using Cockcroft-Gault): < 60 mL/min
    - (i) Common Terminology Criteria for Adverse Events (CTCAE) version 5, grade >= 2 audiometric hearing loss
    - (i) CTCAE version 5, grade >= 2 or above peripheral neuropathy
    - New York Heart Association Class III heart failure
    - (i) Eastern Cooperative Oncology Group (ECOG) performance status = 2
  - (i) Patients who are eligible for cisplatin may be candidates if they refuse available adjuvant chemotherapy, despite being informed by the investigator about the treatment options. The patient's refusal must be documented.
    - (i) Patients with pT2N0 urothelial cancer on cystectomy (without prior neoadjuvant chemotherapy) with ctDNA(+) Signatera results based on an assay performed post-cystectomy as part of routine care outside of the study may proceed with pre-registration but require confirmation of ctDNA(+) Signatera testing on repeat "central testing" in the context of A032103 testing. Patients with pT2N0 with central testing not confirming ctDNA(+) will not be eligible for A032103 (Note: this is distinct from patients with ypT2N0 who are eligible based on ii).
- (ii) Patients who received cisplatin-based neoadjuvant chemotherapy: ypT2-ypT4 or ypT0/x-pT4/N+ on cystectomy
ECOG PS 0-2
No adjuvant systemic threapy after cystectomy
No prior PD-1/L1 inhibitor or LAG-3 blockade

ADVANCED SOLID TUMORS: Phase 1: PD-L1 + novel agent: GO43860

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

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Malignancy

Esophageal, Gastric, Cervical, clear cell renal cell cancer, RCC, hepatocellular carcinoma, HCC, liver cancer, HNSCC, head and neck cancer, oropharyngeal, larynx, hypopharyngeal, oral cavity, melanoma, urothelial carcinoma, bladder cancer, triple-negative breast cancer, TNBC, non-small cell lung cancer, NSCLC, colon, prostate

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

>1st line

Investigational Agent

RO7502175

Drug Class

Anti-CCR8 antibody

Dan Vaena, MD

Sponsor

Genentech, Inc.

Path

Carcinoma

Key Eligibility Criteria Details

Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumors
Must have tumor specimen available
Measurable disease
ECOG PS 0-1
Life expectancy at least 12 weeks
Phase 1a- must have exhausted all standard therapies for their disease
Phase 1b- must have disease that has progressed after at least one available standard therapy
Some cohorts are tumor-type specific- please contact study team to see if tumor type is eligible at any time during the study
No active HBV/HCV or chronic or acute EBV
No history of autoimmune disease
No symptomatic or actively progressing CNS mets