Small-cell Lung CancerPhase 1NCT04173325
Feasibility and Safety Study of Nivolumab With Irinotecan for Small Cell Lung Cancer
A Phase 1 study testing Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] and Irinotecan Injection [Camptosar] in people with Small-cell Lung Cancer and Small Cell Lung Carcinoma, run by Augusta University at 1 site in United States.
Trial summary
This study will determine the frequency of adverse events (side effects) in patients with relapsed or refractory small cell lung cancer (SCLC) when given nivolumab and irinotecan together followed by nivolumab maintenance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small-cell Lung Cancer, Small Cell Lung Carcinoma
- What is being tested?
- Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] and Irinotecan Injection [Camptosar]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 26 May 2022
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed SCLC with known UGT1A genotype.
- Patients who have received at least 1 prior platinum-based chemotherapy.
- Life expectancy of 3 months or more.
- Measurable disease.
Who cannot join
- Patients with UGT1A polymorphism.
- Currently receiving chemotherapy.
- Pregnant and nursing women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Cancer Center at AU Medical Center
Augusta, Georgia, 30912
About this study
Official title: Phase I Feasibility and Safety Study of Nivolumab in Combination With Irinotecan in Relapsed or Refractory Small Cell Lung Cancer (SCLC) Followed by Maintenance Nivolumab
This study will determine the frequency of adverse events (side effects) in patients with relapsed or refractory small cell lung cancer (SCLC) when given nivolumab and irinotecan together followed by nivolumab maintenance. This study will test the safety of the study treatments when given together and see what effect (good or bad) it has on participants and their cancer.
- Conditions
- Small-cell Lung Cancer, Small Cell Lung Carcinoma
- Being tested
- Nivolumab 10 MG/ML Intravenous Solution [OPDIVO], Irinotecan Injection [Camptosar]
- Keywords
- Lung cancer, Relapsed lung cancer
- Medical subject headings
- Small Cell Lung Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]Drug
PD-1 inhibitor approved by the US FDA for treatment of patients with lung cancer.
Irinotecan Injection [Camptosar]Drug
Chemotherapy drug currently FDA approved for treatment of multiple tumors, including small cell lung cancer.
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab and Irinotecan | Experimental | Drug: Nivolumab 360mg IV Day 1 of each 21 day cycle until disease progression or unacceptable toxicity + Drug: Irinotecan 500mg IV Day of each 21 day cycle for 2 cycles Followed by maintenance nivolumab (without irinotecan) Receives: Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]; Drug: Irinotecan Injection [Camptosar] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the frequency and severity of adverse events in patients with small cell lung cancer after receiving nivolumab plus irinotecan followed by nivolumab maintenance.
CTCAE v.4.0. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Overall response rate
Tumor response evaluation with RECIST
Measured: through study completion, an average of 1 year
Progression-free survival (PFS)
PFS as measured from start of therapy till disease progression.
Measured: through study completion, an average of 1 year
Overall survival (OS)
OS as measured from start of therapy till date of death or last follow up assessment.
Measured: through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start6 Jan 2020
- Primary completion26 May 2022
- Study completion26 May 2022
Why it stopped: Closed by the IRB 5/26/22 due to non-compliance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-cell Lung CancerStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagla Abdel Karim, Augusta University
- Investigators
- Nagla A Karim, MD, PhD, Principal investigator, Augusta University Georgia Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173325
- Sponsor's protocol ID
- GCC-20-009
- Status last verified
- Jun 2022
- First submitted
- 14 Nov 2019
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Feasibility and Safety Study of Nivolumab in Combination With Irinotecan in Relapsed or Refractory Small Cell Lung Cancer (SCLC) Followed by Maintenance Nivolumab
- ClinicalTrials.gov ID
- NCT04173325
- Acronym / sponsor ID
- GCC-20-009
- Conditions
- Small-cell Lung Cancer, Small Cell Lung Carcinoma
- Keywords
- Lung cancer, Relapsed lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed by the IRB 5/26/22 due to non-compliance
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 26 May 2022 (actual)
- Study completion
- 26 May 2022 (actual)
- First posted
- 21 Nov 2019 (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.
This study will determine the frequency of adverse events (side effects) in patients with relapsed or refractory small cell lung cancer (SCLC) when given nivolumab and irinotecan together followed by nivolumab maintenance. This study will test the safety of the study treatments when given together and see what effect (good or bad) it has on participants and their cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nivolumab and Irinotecan | Experimental | Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO], Drug: Irinotecan Injection [Camptosar]Drug: Nivolumab 360mg IV Day 1 of each 21 day cycle until disease progression or unacceptable toxicity + Drug: Irinotecan 500mg IV Day of each 21 day cycle for 2 cycles Followed by maintenance nivolumab (without irinotecan) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed SCLC with known UGT1A genotype.
- Patients who have received at least 1 prior platinum-based chemotherapy.
- Life expectancy of 3 months or more.
- Measurable disease.
Key exclusion criteria (3 listed)
- Patients with UGT1A polymorphism.
- Currently receiving chemotherapy.
- Pregnant and nursing women.
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 |
|---|---|---|
| Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]PD-1 inhibitor approved by the US FDA for treatment of patients with lung cancer. | Drug | Nivolumab and Irinotecan |
| Irinotecan Injection [Camptosar]Chemotherapy drug currently FDA approved for treatment of multiple tumors, including small cell lung cancer. | Drug | Nivolumab and Irinotecan |
Primary outcome
Evaluate the frequency and severity of adverse events in patients with small cell lung cancer after receiving nivolumab plus irinotecan followed by nivolumab maintenance.
Time frame: through study completion, an average of 1 year
CTCAE v.4.0. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
3 secondary outcomes
Overall response rate
Time frame: through study completion, an average of 1 year
Progression-free survival (PFS)
Time frame: through study completion, an average of 1 year
Overall survival (OS)
Time frame: through study completion, an average of 1 year.
Results and safety
The study was stopped early (reason given: Closed by the IRB 5/26/22 due to non-compliance). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
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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.
Nagla A Karim, MD, PhD principal investigator
Augusta University Georgia Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] and Irinotecan Injection [Camptosar] in people with Small-cell Lung Cancer and Small Cell Lung Carcinoma, run by Augusta University 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 14 Jun 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early (reason given: Closed by the IRB 5/26/22 due to non-compliance). Results are not available in the source record.
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?
Evaluate the frequency and severity of adverse events in patients with small cell lung cancer after receiving nivolumab plus irinotecan followed by nivolumab maintenance. (time frame: through study completion, an average of 1 year). 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 14 Jun 2022.