Resectable Biliary Tract CancerPhase 2NCT03768531
Safety and Tolerability Study of Nivolumab and Cabiralizumab for Resectable Biliary Tract Cancer
A Phase 2 study testing Nivolumab and Cabrilizumab in people with Resectable Biliary Tract Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
Trial summary
The purposed of this research is to study the safety and clinical activity of the combination of nivolumab and cabiralizumab in people with resectable biliary tract cancers (BTC). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Resectable Biliary Tract Cancer
- What is being tested?
- Nivolumab and Cabrilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 14 Jun 2019to Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has confirmed biliary tract cancer
- Ability to understand and willingness to sign a written informed consent document.
- Age ≥18 years
- Have biopsiable disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Patient must have adequate organ function defined by the study-specified laboratory tests.
- Must use acceptable form of birth control while on study.
Who cannot join
- Has active autoimmune disease that requires systemic treatment.
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years or that is expected to require active treatment within two years.
- Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).
- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Has evidence of an uncontrolled, active infection requiring parenteral anti-bacterial, anti-viral or anti-fungal therapy ≤ 7 days prior to administration of study medication.
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- Has received a blood transfusion within 72 hours prior to first dose of study drug administration
- Unwilling or unable to follow the study schedule for any reason.
- Major surgery within 4 weeks prior to initiation of study treatment.
- Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant muscle disorders or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or breastfeeding women.
- Have known history of infection with HIV, hepatitis B, or hepatitis C.
- Received any prophylactic vaccine within 30 days of first dose of study drug treatment.
- Has a history of allergy to study treatments or any of its components of the study.
About this study
Official title: Safety and Tolerability Study of Combination Nivolumab and Cabiralizumab as Neoadjuvant and Adjuvant Therapy for Resectable Biliary Tract Cancer
The purposed of this research is to study the safety and clinical activity of the combination of nivolumab and cabiralizumab in people with resectable biliary tract cancers (BTC).
- Conditions
- Resectable Biliary Tract Cancer
- Being tested
- Nivolumab, Cabrilizumab
- Keywords
- Nivolumab, Cabiralizumab, Immunotherapy, Anti-PD-1, Anti-CSF-1R, Biliary tract cancers (BTC), Neoadjuvant chemotherapy, Adjuvant chemotherapy, Tumor microenvironment
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called OPDIVO; BMS-936558-01
Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes every 2 weeks. (Cycle length 2 weeks).
CabrilizumabDrug
Also called FPA008, BMS-986227
Cabiralizumab 4 mg/kg given IV for 30 minutes, 30 minutes after Nivolumab infusion is completed, every 2 weeks. (Cycle length 2 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Nivolumab | Experimental | Not described Receives: Drug: Nivolumab |
| Arm B: Nivolumab and Cabrilizumab | Experimental | Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes, a 30 minute rest, followed by cabiralizumab every 2 weeks. (Cycle length 2 weeks). Receives: Drug: Nivolumab; Drug: Cabrilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing study drug-related toxicities
Number of participants experiencing drug-related adverse events as defined by CTCAE v5.0
Measured: 4 years
Secondary outcomes (2)
Overall survival (OS)
Number of months from the date of first treatment until death or end of follow-up.
Measured: 4 years
Disease free survival (DFS)
Number of months until disease recurrence.
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start14 Jun 2019
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Why it stopped: No subjects were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Adrian Murphy, MD, Principal investigator, Johns Hopkins Medical Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768531
- Sponsor's protocol ID
- J18162
- Other IDs
- IRB00185328
- Status last verified
- Apr 2020
- First submitted
- 5 Dec 2018
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability Study of Combination Nivolumab and Cabiralizumab as Neoadjuvant and Adjuvant Therapy for Resectable Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT03768531
- Acronym / sponsor ID
- J18162
- Conditions
- Resectable Biliary Tract Cancer
- Keywords
- Nivolumab, Cabiralizumab, Immunotherapy, Anti-PD-1, Anti-CSF-1R, Biliary tract cancers (BTC), Neoadjuvant chemotherapy, Adjuvant chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects were enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposed of this research is to study the safety and clinical activity of the combination of nivolumab and cabiralizumab in people with resectable biliary tract cancers (BTC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Nivolumab | Experimental | Drug: Nivolumab |
| Arm B: Nivolumab and Cabrilizumab | Experimental | Drug: Nivolumab, Drug: CabrilizumabNivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes, a 30 minute rest, followed by cabiralizumab every 2 weeks. (Cycle length 2 weeks). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has confirmed biliary tract cancer
- Ability to understand and willingness to sign a written informed consent document.
- Age ≥18 years
- Have biopsiable disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Key exclusion criteria (14 listed)
- Has active autoimmune disease that requires systemic treatment.
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years or that is expected to require active treatment within two years.
- Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).
- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: OPDIVO; BMS-936558-01Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes every 2 weeks. (Cycle length 2 weeks). | Drug | Arm A: Nivolumab, Arm B: Nivolumab and Cabrilizumab |
| CabrilizumabAlso: FPA008, BMS-986227Cabiralizumab 4 mg/kg given IV for 30 minutes, 30 minutes after Nivolumab infusion is completed, every 2 weeks. (Cycle length 2 weeks). | Drug | Arm B: Nivolumab and Cabrilizumab |
Primary outcome
Number of participants experiencing study drug-related toxicities
Time frame: 4 years
Number of participants experiencing drug-related adverse events as defined by CTCAE v5.0
2 secondary outcomes
Overall survival (OS)
Time frame: 4 years
Disease free survival (DFS)
Time frame: up to 4 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Murphy, MD principal investigator
Johns Hopkins Medical Institution
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and Cabrilizumab in people with Resectable Biliary Tract Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
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 7 inclusion and 14 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: withdrawn, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of participants experiencing study drug-related toxicities (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2020.