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Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma

ConditionsPleural Biphasic MesotheliomaPleural Sarcomatoid Mesothelioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlliance for Clinical Trials in Oncology

About this trial

This phase II trial evaluates the safety and effectiveness of giving immunotherapy (nivolumab and ipilimumab) before surgery for controlling disease in patients with stage I-IIIa sarcomatoid mesothelioma. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving immunotherapy before surgery may be more effective at controlling disease in patients with sarcomatoid mesothelioma than giving immunotherapy alone.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sarcomatoid or sarcomatoid-dominant (> 50%) biphasic, pleural mesothelioma

Stage: I-IIIA disease per Union for International Cancer Control (UICC) TNM Classification of Malignant Tumours 8th edition

Measurable disease or non-measurable disease as defined

No prior treatment which would be considered treatment for the primary neoplasm or impact the primary endpoint

Disqualifiers

No patients deemed to be unresectable or poor surgical candidates

No patients with chest wall invasion, peritoneal spread, contralateral pleural involvement, mediastinal organ involvement, vertebral involvement, or metastases to contralateral intrathoracic lymph nodes, or any supraclavicular nodes

No patients with a history of symptomatic interstitial lung disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Nivolumab

    Biological/Vaccine

    Given IV

  • Ipilimumab

    Biological/Vaccine

    Given IV

  • Surgical Procedure

    Procedure/Surgery

    Undergo surgery

  • Computed Tomography

    Procedure/Surgery

    undergo CT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: Treatment (nivolumab, ipilimumab, surgery)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Surgery Rate

The rate of surgery after neoadjuvant immunotherapy among the feasibility analysis population as well as the 80% and 95% exact Clopper-Pearson confidence intervals will be estimated.

Time frame
immediately after the completion of neoadjuvant immunotherapy and surgery
2

Progression free survival (PFS)

PFS will be determined per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The rate of PFS at 12 months after the initiation of neoadjuvant immunotherapy among the feasibility and efficacy analysis population as well as the 80% and 95% exact Clopper-Pearson confidence intervals will be estimated.

Time frame
At 12 months after initiation of neoadjuvant immunotherapy

Secondary outcomes

1

Incidence of adverse events

The type of adverse events, the frequency of each type and its grade will be summarized. The frequency and the percentage of severe adverse events will be presented in bar charts over treatment phase (neoadjuvant immunotherapy, surgery) to describe the change of adverse event or complication severity over time. The rates of the pre-operative or post-operative complications (within 30 days of surgery) will be estimated with its exact 95% confidence interval.

Time frame
Up to 5 years
2

Objective response rate

Will be determined per modified RECIST. Response rate will be reported with 95% exact confidence interval.

Time frame
Up to 5 years
3

Major pathologic response

Defined as =\< 10% residual viable tumor in the resected lung and lymph node tissue. Response rates will be reported with 95% exact confidence interval.

Time frame
Up to 5 years
4

Time to recurrence

Time to recurrence will be estimated among those patients who receive surgery and will be characterized by estimating cumulative incidence function and conducting cause-specific and subdistribution hazard regression.

Time frame
Time from surgery to disease relapse, progression, or second tumor, whichever occurs first, assessed up to 5 years

Other outcomes

1

Biomarkers

The association of pre-treatment and on-treatment biomarkers in peripheral blood and in tumor tissues with response and time to recurrence, will be evaluated univariately through Chi-square test or log-rank test and through logistic regression model or Cox regression model with other prognostic factors adjusted.

Time frame
Up to 5 years

Sponsors and contacts

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

Alliance for Clinical Trials in Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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