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Checkpoint Inhibitor

Nivolumab plus Ipilimumab for Neuroendocrine Tumors

Phase 2
Waitlist Available
Led By Christine Hann, MD/PhD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 3 years 8 months
Awards & highlights

Study Summary

This trial is testing a combination of two drugs, Nivolumab and Ipilimumab, to treat patients with advanced neuroendocrine tumors.

Eligible Conditions
  • Neuroendocrine Tumors
  • Carcinoid Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 3 years 8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 years 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) of Neuroendocrine Tumor (NET) of the Lung, Pancreas, and Gastrointestinal (GI) Tract
Secondary outcome measures
Efficacy as Assessed by Disease Control Rate (DCR)
Efficacy as Assessed by Duration of Response (DOR)
Efficacy as Assessed by Overall Survival (OS)
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nivolumab plus IpilimumabExperimental Treatment2 Interventions
Nivolumab 240 mg IV over 60 minutes every 2 weeks (Q2W) Ipilimumab 1mg/kg IV over 30 minutes every 6 weeks (Q6W)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,505 Total Patients Enrolled
4 Trials studying Neuroendocrine Tumors
450 Patients Enrolled for Neuroendocrine Tumors
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,891 Total Patients Enrolled
Christine Hann, MD/PhDPrincipal InvestigatorJohns Hopkins University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still able to sign new participants up for this research project?

"The trial, which was posted on March 9th 2018 and last updated May 26th 2022 is not currently looking for participants. That said, there are 3368 other trials actively recruiting patients."

Answered by AI

Could you please elaborate on other scientific research that has been done using this same treatment method?

"Presently, there are 796 active trials researching this intervention with 86 in Phase 3. A few of the clinical trials for this treatment will soon end in Pittsburgh, Pennsylvania; however, there are 43300 locations conducting studies for this treatment."

Answered by AI

What are the main indications for this medication?

"This treatment can be used to help patients who have previously undergone anti-angiogenic therapy, as well as those suffering from malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

Could you please list the age requirements for this clinical trial?

"The age limit for this particular trial is 18 to 100 years old. There are 387 other trials that cater exclusively to patients below the age of 18 and 3157 for those above 65."

Answered by AI

Has this therapeutic intervention been cleared by the FDA?

"While Phase 2 trials don't have the same level of data supporting efficacy, this treatment received a safety score of 2 from our team at Power."

Answered by AI

Are there any inclusion/exclusion criteria for this particular research project?

"This study is looking for 9 people who have argentaffinoma and meet the following criteria: - Ages 18 to 100- ECOG performance status ≤ 1 (see Appendix 1)- Prior palliative radiotherapy to non-CNS lesions must have been completed at least 2 weeks prior to treatment. Subjects with symptomatic tumor lesions at baseline that may require palliative radiotherapy within 4 weeks of first treatment are strongly encouraged to receive palliative radiotherapy prior to treatment.- Patients with lung NETs must have progressed after at least 1 line of therapy. Patients with GI NETs must"

Answered by AI

What are researchers hoping to achieve with this clinical trial?

"The primary aim of this clinical trial, which will use a 6 week post-intervention timeframe, is to assess the Objective Response Rate (ORR) of neuroendocrine tumors (NETs) in patients with lung cancer. Secondary outcome measures include efficacy as assessed by disease control rate (DCR), defined as the percentage of participants who achieve partial or complete response to treatment; duration of response (DOR), defined as the number of months from documentation of tumor response to disease progression; and overall survival (OS), defined as the number of months participants stay alive after treatment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Nivolumab With Ipilimumab in Subjects With Neuroendocrine Tumors
2018. "Nivolumab With Ipilimumab in Subjects With Neuroendocrine Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03420521.
~1 spots leftby Apr 2025
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