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Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer

ConditionsAdvanced Clear Cell Renal Cell CarcinomaMetastatic Clear Cell Renal Cell CarcinomaStage III Renal Cell Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSWOG Cancer Research Network

About this trial

This phase III trial compares the effect of adding live biotherapy, MO-03, to standard of care (SOC) immunotherapy, including ipilimumab, nivolumab, axitinib, pembrolizumab, cabozantinib, and lenvatinib, to SOC immunotherapy alone in treating patients with clear cell renal cell cancer that may have spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started to other places in the body (metastatic). Studies have shown that gut health (the gut microbiome) may impact the effectiveness of immunotherapy. The microbiome includes all of the bacteria and organisms naturally found in the digestive tract. MO-03, a type of biotherapy, contains material from living organisms that may help keep the digestive tract healthy and may help to increase the effect of immunotherapy. Immunotherapy with monoclonal antibodies, such as ipilimumab, nivolumab, pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are a type of angiogenesis inhibitor and tyrosine kinase inhibitor (TKI) that block certain proteins which may help keep tumor cells from growing and may also help prevent the growth of new blood vessels that tumors need to grow. Adding MO-03 to SOC immunotherapy may be more effective than SOC immunotherapy alone in treating patients with advanced or metastatic clear cell renal cell cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have histologically confirmed renal cell carcinoma (RCC) with clear cell component that is advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC at the time of registration on study

Participants must have measurable/evaluable disease by RECIST 1.1 criteria. Participants with only bone metastases or only pleural effusions are considered evaluable disease and are eligible

Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease must not require immediate central nervous system (CNS) specific treatment at the time of study registration or anticipated treatment during the first cycle of therapy

Participants must not be currently enrolled or plan to participate in treatment studies while enrolled on this study

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Axitinib

    Drug

    Given PO

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Scan

    Procedure/Surgery

    Undergo bone scan

  • Cabozantinib

    Drug

    Given PO

  • Clostridium butyricum CBM 588 Probiotic Strain

    Drug

    Given PO

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Ipilimumab

    Biological/Vaccine

    Given IV

  • Lenvatinib

    Drug

    Given PO

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Nivolumab

    Biological/Vaccine

    Given IV

  • Nivolumab and Recombinant Human Hyaluronidase

    Drug

    Given SC

  • Pembrolizumab

    Biological/Vaccine

    Given IV

  • Placebo Administration

    Drug

    Given PO

Treatment groups

718 Participants
are divided into 2 treatment groups
Group A: Arm 1 (MO-03, SOC immunotherapy)Experimental treatment 12 interventions
Group B: Arm 2 (placebo, SOC immunotherapy)Placebo comparator 12 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

A Cox model will be used to test the treatment hazard ratio with stratification factors in the model as covariates for the futility and efficacy interim analyses and the final analysis.

Time frame
From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 5 years

Secondary outcomes

1

Incidence of adverse events (AEs) (Safety run-in)

Will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The rate and severity of toxicities on the active arm will be compared to the placebo arm to provide context for the background rate of toxicities attributable to the standard of care regimens.

Time frame
During the first 12 weeks (2 cycles [cycle length =42 days])
2

Overall survival

Will report the hazard ratio and 95% confidence interval for blinded study agent with respect to overall survival with stratification in the Cox model for the stratification factors.

Time frame
From date of randomization to date of death due to any cause, assessed up to 5 years
3

PFS rates between the study arms

Estimates of treatment effect and the corresponding 95% confidence interval will be provided for the PFS endpoint for sex, race, and ethnicity.

Time frame
At 12 and 24 months
4

Incidence of AEs between study arms

Will be assessed according to the NCI CTCAE v 5.0. The rate and severity of toxicities on the active arm will be compared to the placebo arm to provide context for the background rate of toxicities attributable to the standard of care regimens.

Time frame
Up to 90 days after last dose of study treatment

Other outcomes

Sponsors and contacts

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

SWOG Cancer Research Network

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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