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Nivolumab + Ipilimumab for Solid Tumors

Phase 1 & 2

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with histologically or cytologically confirmed locally advanced or metastatic disease of the following tumor types: Triple Negative Breast Cancer, Gastric Cancer, Pancreatic Cancer, Small Cell Lung Cancer, Bladder Cancer, Ovarian Cancer

Eastern Cooperative Oncology Group (ECOG) of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 months

Awards & highlights

Study Summary

This trial is investigating the safety and efficacy of the immunotherapy drugs nivolumab and ipilimumab, either alone or in combination with other drugs, in six different types of cancer.

Who is the study for?

This trial is for adults with certain advanced or metastatic solid tumors: triple-negative breast, gastric, pancreatic, small cell lung, bladder, or ovarian cancer. Participants should be in good physical condition (ECOG 0-1) and have measurable disease. They can't join if they have active brain metastases, autoimmune diseases, need systemic steroids or immunosuppressants within 14 days of treatment start, or previously used specific anti-tumor vaccines and T cell targeting therapies.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of Nivolumab alone or combined with Ipilimumab in treating six types of solid tumors. Additionally, a combination of Nivolumab with Ipilimumab and Cobimetinib is being tested specifically for pancreatic cancer to see how well these treatments work.See study design

What are the potential side effects?

Possible side effects include immune-related reactions that may affect organs like the liver or lungs; skin rash; hormone gland problems (like thyroid); infusion reactions; fatigue; digestive issues such as diarrhea; and potential increase in infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is one of the specified types and is advanced or has spread.

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I can perform all my usual activities without assistance.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 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 )

Trial Design

6Treatment groups

Experimental Treatment

Group I: Arm N-I, Level 2d: Nivolumab+Ipilimumab+CobimetinibExperimental Treatment3 Interventions

Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks and cobimetinib 60mg once daily 21days on/7 days off until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Group II: Arm N-I, Level 2c: Nivolumab+IpilimumabExperimental Treatment2 Interventions

Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Group III: Arm N-I, Level 2b: Nivolumab+IpilimumabExperimental Treatment2 Interventions

Nivolumab 3 mg/kg solution intravenously plus Ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Group IV: Arm N-I, Level 2: Nivolumab+IpilimumabExperimental Treatment2 Interventions

Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 3 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Group V: Arm N-I, Level 1: Nivolumab+IpilimumabExperimental Treatment2 Interventions

Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 1 mg/kg solution every 3 weeks for 4 doses followed by Nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Group VI: Arm N - NivolumabExperimental Treatment1 Intervention

Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

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

Cobimetinib

2017

Completed Phase 3

~2660

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,127,351 Total Patients Enrolled

Media Library

Cobimetinib (Other) Clinical Trial Eligibility Overview. Trial Name: NCT01928394 — Phase 1 & 2

Solid Tumors Research Study Groups: Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib, Arm N - Nivolumab, Arm N-I, Level 1: Nivolumab+Ipilimumab, Arm N-I, Level 2: Nivolumab+Ipilimumab, Arm N-I, Level 2b: Nivolumab+Ipilimumab, Arm N-I, Level 2c: Nivolumab+Ipilimumab

Solid Tumors Clinical Trial 2023: Cobimetinib Highlights & Side Effects. Trial Name: NCT01928394 — Phase 1 & 2

Cobimetinib (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01928394 — Phase 1 & 2

Frequently Asked Questions

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

Are there multiple sites within this state offering participation in the trial?

"The trial has assigned 26 distinct sites for enrolling patients. These locations include Local Institution - 0004 in Baltimore, Local Institution - 0003 in Charlotte, and Local Institution - 0011 in Franklin among other places of enrolment."

Answered by AI

What previous research has been conducted concerning the efficacy of Ipilimumab?

"Currently, 812 trials researching Ipilimumab are in progress with 89 of those studies at Phase 3. The majority are based in Pittsburgh; however, there exists a wide array of research centres involving 43904 locations that have clinical trial data for this drug."

Answered by AI

Is participation in this experiment available to volunteers right now?

"This specific trial is no longer open for enrolment. It was initially created on October 24th 2013 and last modified on September 21st 2022, yet there are still plenty of other trials available: 2,388 studies studying cancer and 812 dedicated to the use of Ipilimumab specifically."

Answered by AI

What medical conditions can be remedied through the use of Ipilimumab?

"Ipilimumab is typically used to treat patients after prior anti-angiogenic therapy, as well as for multiple other medical issues like malignant neoplasms and unresectable melanoma. Furthermore, it can be effective against squamous cell carcinoma."

Answered by AI

What is the current enrolment size of this research project?

"This trial is no longer seeking participants. It was initially posted on October 24th 2013, and last updated on September 21st 2022. However, there are 2388 cancer trials and 812 Ipilimumab studies currently in recruitment mode."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Nivolumab Alone and with Ipilimumab in Previously Treated Metastatic Urothelial Carcinoma: Checkmate 032 Nivolumab 1 Mg/kg Plus Ipilimumab 3 Mg/kg Expansion Cohort Results

Sharma, Padmanee, Arlene Siefker-Radtke, Filippo de Braud, Umberto Basso, Emiliano Calvo, Petri Bono, Michael A. Morse, et al.. 2019. “Nivolumab Alone and with Ipilimumab in Previously Treated Metastatic Urothelial Carcinoma: Checkmate 032 Nivolumab 1 Mg/kg Plus Ipilimumab 3 Mg/kg Expansion Cohort Results”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.19.00538.

Journal of Clinical OncologyJournal

Checkmate-032 Study: Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Patients with Metastatic Esophagogastric Cancer

Janjigian, Yelena Y., Johanna Bendell, Emiliano Calvo, Joseph W. Kim, Paolo A. Ascierto, Padmanee Sharma, Patrick A. Ott, et al.. 2018. “Checkmate-032 Study: Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Patients with Metastatic Esophagogastric Cancer”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2017.76.6212.

Journal of Clinical OncologyJournal

Alterations in DNA Damage Response and Repair Genes as Potential Marker of Clinical Benefit from PD-1/PD-L1 Blockade in Advanced Urothelial Cancers

Teo, Min Yuen, Kenneth Seier, Irina Ostrovnaya, Ashley M. Regazzi, Brooke E. Kania, Meredith M. Moran, Catharine K. Cipolla, et al.. 2018. “Alterations in DNA Damage Response and Repair Genes as Potential Marker of Clinical Benefit from PD-1/PD-L1 Blockade in Advanced Urothelial Cancers”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2017.75.7740.

The Lancet OncologyJournal