AzTrials
AzTrials

MesotheliomaPhase 2NCT05041062

A Study of Immunotherapy Drugs Nivolumab and Ipilimumab in Patients w/Resectable Malignant Peritoneal Mesothelioma

A Phase 2 study testing Nivolumab and Ipilimumab in people with Mesothelioma and Peritoneal Mesothelioma, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is for individuals who have peritoneal mesothelioma, a cancer of the lining of your abdominal wall and organs (the peritoneum). Doctors leading the study would like to determine the effects of treating this cancer with immunotherapy drugs (nivolumab and ipilimumab - the two study drugs that will be used in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mesothelioma, Peritoneal Mesothelioma
What is being tested?
Nivolumab and Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
1 Dec 2021to 13 Apr 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a diagnosis of histologically or cytologically confirmed peritoneal mesothelioma, of epithelial, biphasic, or sarcomatoid subtypes
  • Have disease burden amenable to cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC), as determined by a surgeon specializing in mesothelioma
  • Have measurable or evaluable disease based on RECIST 1.1 or on laparoscopy
  • Have no definitive evidence of visceral metastases by best staging
  • Be willing to undergo laparoscopy or mini-laparotomy for peritoneal staging
  • Adequate organ function as determined by screening labs,
Show all 9Show fewer
  • Have an ECOG performance status of < 2
  • Be 18 years of age on day of signing informed consent
  • Be willing and able to provide written informed consent for the trial

Who cannot join

  • Is currently participating in a study of an investigational agent and received an investigational agent within 4 weeks of the first dose of treatment on this protocol
  • Has received any immunotherapy agents outside of this protocol within 4 weeks of the first dose of treatment on this protocol
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (>10 mg of prednisone daily or equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose of study drug.
  • Has a known history of active TB infection (Bacillus tuberculosis)
  • Has active COVID-19 infection
  • Has known history of, or any evidence of active, non-infectious pneumonitis that required steroids, or active pneumonitis
Show all 19Show fewer
  • Has a severe hypersensitivity to nivolumab or any of its excipients
  • Has a severe hypersensitivity to ipilimumab or any of its excipients
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
  • Has a known additional malignancy that is progressing or required active treatment within the 3 years prior to enrollment - exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or other tumors that will not affect life expectancy
  • Has an active infection requiring systemic therapy
  • Has a known history of HIV, Hepatitis B, or Hepatitis C
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment
  • Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (Reference Section 5.8.2). Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
  • Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
  • Is on anticoagulation that cannot be discontinued in the perioperative period
  • Has received a live vaccine within 30 days of planned start of study therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Chicago

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: A Phase II Prospective, Open-label Trial of Perioperative Combination Nivolumab and Ipilimumab in Patients With Resectable Malignant Peritoneal Mesothelioma

This study is for individuals who have peritoneal mesothelioma, a cancer of the lining of your abdominal wall and organs (the peritoneum). Doctors leading the study would like to determine the effects of treating this cancer with immunotherapy drugs (nivolumab and ipilimumab - the two study drugs that will be used in this study) before and after surgery.

Doctors hope to learn if giving these two drugs before surgery will decrease the amount of viable (live) cancer cells that remain at the time of surgery and whether it will delay the time it could take for the cancer to regrow.

Being tested
Nivolumab, Ipilimumab
Keywords
chest cancer, abdominal cancer, lung cancer, cancer in lining of lungs
Medical subject headings
Mesothelioma, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Also called Opdivo, ONO-4538, BMS-936558, MDX1106

    Nivolumab is an immunotherapy drug (a type of drug that helps your immune system fight cancer) that is often used with ipilimumab as the first treatment in adults with mesothelioma whose disease cannot be removed by surgery. The drug will be given as an IV infusion.

  • IpilimumabDrug

    Also called Yervoy

    Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps your own immune system attack cancer cells.

Study groups in NCT05041062
Study groupRoleWhat they receive
All Participants in Study Who Have MesotheliomaExperimentalIndividuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. There will also be a follow up period to determine how well the drugs and surgery worked to get rid of your cancer. Your overall participation in this study (including drug treatment, surgery and follow up visits) will last for roughly one and a half years. All eligible participant who enroll in the study will participate in this group.
Receives: Drug: Nivolumab; Drug: Ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Pathologic (Disease) Response of Tumor to Nivolumab Combined With Ipilimumab Before Surgery

    The response of participant's tumor to treatment with nivolumab and ipilimumab before surgery by analyzing tissue samples collected from participant during surgery for the presence of cancerous tumour cells. Major pathologic response will be defined as tissue samples containing less than or equal to 10% of residual (leftover) tumor/cancer in the tissue after surgery.

    Measured: 24 months

Secondary outcomes (7)

  1. Rate of Participants Who Report Serious Side Effects to Nivolumab Combined With Ipilimumab Before Surgery (Neoadjuvant Treatment)

    The rate of participants who report Grade 3 or 4 serious adverse events (side effects) after taking nivolumab combined with ipilimumab before surgery. These side effects will be measured according to Common Terminology Criteria for Adverse Events v5.0 for up to 30 days after surgery.

    Measured: 3 weeks (timeframe for surgery ) + 30 days (timeframe for assessing side effects after surgery)

  2. Number of Participants Who Proceed to Surgery Without Delays After Receiving Nivolumab Combined With Ipilimumab

    Number of participants who complete treatment with nivolumab and ipilimumab before surgery and proceed to surgery without extended treatment-related delays or progression precluding surgery as assessed by clinical /study records.

    Measured: 19 weeks

  3. Overall Survival of Participants Who Take Nivolumab Combined With Ipilimumab Before Surgery

    Overall survival of participants who receive neoadjuvant nivolumab combined with ipilimumab, defined as time from enrollment on study to death from any cause.

    Measured: 42 Months

  4. Progression-Free Survival of Participants Who Take Nivolumab Combined With Ipilimumab Before Surgery

    Progression-free survival of participants who receive neoadjuvant nivolumab combined with ipilimumab, defined as time from enrollment on study to death from any cause.

    Measured: 42 months

  5. Rate of Participants Who Report Serious Side Effects to Taking Nivolumab Combined With Ipilimumab After Surgery (Adjuvant Treatment)

    The rate of participants who report Grade 3 or 4 serious adverse events (side effects) after taking nivolumab combined with ipilimumab after surgery. These side effects will be measured according to Common Terminology Criteria for Adverse Events v5.0.

    Measured: 12 weeks

  6. Radiologic Response to Nivolumab and Ipilimumab Before Surgery

    Radiologic response to nivolumab and ipilimumab before surgery using radiology images of tumor pre- and post-treatment.

    Measured: 24 months

  7. Peritoneal Carcinomatosis Index (PCI) of Participants Who Taking Nivolumab Combined With Ipilimumab Before Surgery

    The effect of nivolumab and ipilimumab on participant's tumor as assessed by a peritoneal carcinomatosis index (PCI) score, a score determined based on the size of participant's tumor after abdominal surgery.

    The Peritoneal Cancer Index (PCI) scoring system is a diagnostic and prognostic tool. The PCI score is calculated by dividing the peritoneal (abdominal) cavity into 13 regions and assigning a score to each of the 13 regions. Each region receives a score of 0-3 based on the largest tumor size in each region. The total sum of all 13 regions is the PCI score. PCI scores can range from 0 to 39. Higher scores indicate more widespread and/or larger tumors in the peritoneal cavity.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2021
  2. Study start1 Dec 2021
  3. Primary completion13 Apr 2023
  4. Study completion13 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05041062
Sponsor's protocol ID
IRB21-0672
Status last verified
Dec 2023
First submitted
7 Sep 2021
Last updated
3 Jan 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab and Ipilimumab in people with Mesothelioma and Peritoneal Mesothelioma, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Pathologic (Disease) Response of Tumor to Nivolumab Combined With Ipilimumab Before Surgery (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05041062.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in