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CBM588 Capsules in Combination With Nivolumab and Ipilimumab for the Treatment of Advanced Stage Kidney Cancer

ConditionsAdvanced Clear Cell Renal Cell CarcinomaAdvanced Renal Cell CarcinomaAdvanced Sarcomatoid Renal Cell CarcinomaMetastatic Clear Cell Renal Cell CarcinomaMetastatic Renal Cell CarcinomaMetastatic Sarcomatoid Renal Cell CarcinomaStage III Renal Cell Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOsel, Inc.

About this trial

This phase I trial tests the safety, side effects, best dose, and effectiveness of CBM588 in combination with nivolumab and ipilimumab in treating patients with kidney cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). CBM588 is a live biotherapeutic that may help improve the effects of immunotherapy. Nivolumab and ipilimumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread by enhancing the ability of the body's immune cells to attack tumor cells. CBM588 in combination with nivolumab and ipilimumab may be safe, tolerable, and/or effective in treating patients with advanced stage kidney cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented informed consent of the participant and/or legally authorized representative

Assent, when appropriate, will be obtained per institutional guidelines

Agreement to allow the use of archival tissue from diagnostic tumor biopsies

If unavailable, exceptions may be granted with study principle investigator (PI) approval

Disqualifiers

Prior treatment with ipilimumab and/or nivolumab

Current use, or intent to use, probiotics, yogurt, or bacterial fortified foods during the period of treatment

History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent

Active interstitial lung disease (ILD)/pneumonitis or history of ILD/pneumonitis requiring treatment with systemic steroids

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Scan

    Procedure/Surgery

    Undergo bone scan

  • CBM588 Capsules

    Biological/Vaccine

    Given PO

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Ipilimumab

    Biological/Vaccine

    Given IV

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Nivolumab

    Biological/Vaccine

    Given IV

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Treatment (CBM588 capsules, nivolumab, ipilimumab)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Dose limiting toxicity (DLT)

Toxicities at least possibly related to study agent will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.

Time frame
Up to 28 days
2

Maximum tolerated dose (MTD)

MTD estimate will be the highest dose with the occurrence of DLT in no more than 1 out of 6 of the patients.

Time frame
Up to 28 days
3

Incidence of adverse events (AEs)

AEs will be graded using CTCAE. Summaries will be provided overall and by dose group. The number and percentage of subjects reporting treatment-emergent AEs (TEAE) will be summarized overall and by the worse CTCAE grade, with a breakdown by dose. The number and percentage of subjects reporting TEAEs considered related to each study drug will be summarized.

Time frame
Up to 3 years

Secondary outcomes

1

Progression free survival (PFS)

PFS will be defined as the duration of time from start of treatment to time of progressive disease or death, whichever occurs first. PFS will be estimated using the Kaplan-Meier method. The difference in PFS across dose levels will be explored using the log-rank test. Median PFS time for each dose level will be reported, and the Cox proportional hazard model will be used to estimate the hazard ratio and its confidence interval without adjustment for clinically relevant covariates.

Time frame
From enrollment to progression or death, assessed up to 3 years
2

Overall response rate (ORR)

Evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The best overall response is the best response recorded from the start of the treatment until disease progression or recurrence. ORR will be calculated as the number of patients with complete or partial response divided by the total number of treated/evaluable subjects. ORR will be summarized by dose levels, number, and percentage, along with corresponding exact 95% confidence interval. The association between dose level and overall response as per RECIST v1.1 criteria will be examined using Fisher's exact test.

Time frame
Up to 3 years
3

Change in stool microbial diversity

The Shannon index will be computed from whole metagenome sequence data from stool samples to compare microbial diversity between baseline and 12 weeks and between the two study arms. The index takes into account the number of species (richness) and their relative abundance (evenness). A higher Shannon index indicates greater microbial diversity. The minimum value the Shannon diversity index can take is 0 (one species) and there is no upper limit to the index.

Time frame
Baseline to week 12 of therapy
4

Change in abundancies of gut microbiome species

The taxonomic composition of the microbiome will be determined from whole metagenome sequencing of stool samples and the relative abundancies of species will be compared between baseline and 12 weeks and between the two study arms. The relative abundancies will vary from 0 to 1.

Time frame
Baseline to week 12 of therapy

Other outcomes

Sponsors and contacts

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

Osel, Inc.

Lead sponsor

City of Hope Medical Center

Collaborator

Miyarisan Pharmaceuticals, Co., Ltd.

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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