Small-cell Lung CancerPhase 1NCT04610658

Immune Checkpoint Inhibition With Lurbinectedin Relapsed/Recurrent SCLC

A Phase 1 study testing Nivolumab, Ipilimumab and Lurbinectedin in people with Small-cell Lung Cancer and Relapsed Small Cell Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a single-arm, phase I/II trial to determine the Maximum Tolerated Dose (MTD), Recommended Phase II Dose (RP2D), and the safety and efficacy of the combination of nivolumab-ipilimumab plus lurbinectedin in patients with relapsed/recurrent small cell lung cancer after progression with first-line, platinum-based… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Small-cell Lung Cancer, Relapsed Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer
What is being tested?: Nivolumab, Ipilimumab and Lurbinectedin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 2 sitesUnited States
Study dates: 23 Nov 2020to 24 Mar 2023
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

Measurable disease based on RECIST v1.1
Performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
Adequate organ function as defined per protocol
Women of child bearing potential (WOCBP) must have a negative urine or serum pregnancy test within 72 hours from receiving first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
WOCBP should agree to use 2 methods of birth control or abstain from heterosexual activity for the course of the study through 5 months after the last dose of study medication, or should be surgically sterile. Note: A woman is considered to be of "reproductive potential" (WOCBP) if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures, she is responsible for beginning contraceptive measures.
Male participants should agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy.
Note: In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (vasectomy). However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures, he is responsible for beginning contraceptive measures.

Who cannot join

Individuals meeting any of the following criteria will be excluded from participation in this study:
Is currently participating in a study of an investigational agent or device and received or used the investigational agent or device within 4 weeks of the first dose of treatment.
Has a diagnosis of immunodeficiency or is receiving systemic steroid or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment. Note: Systemic steroid doses of ≤ 10 mg of prednisone daily or its equivalent are allowed in patients receiving physiologic replacement steroid doses
Has a known history of active Bacillus Tuberculosis (TB)
Hypersensitivity to Lurbinectedin, Ipilimumab and/or nivolumab or any of its excipients.
Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.

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Has had targeted small molecule therapy, or standard fractionated radiotherapy within 2 weeks, chemotherapy within 3 weeks and stereotactic radiotherapy within 1 week prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Note:: Participants with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Has a known additional malignancy that is progressing or requires active treatment. 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. Other malignancies that remain without evidence of disease or recurrence, 2 years or more after curative therapy are also considered part of this exception.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 2 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
Has any of the following concomitant diseases/conditions:
History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year.
Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment.
History of idiopathic, pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis or evidence of active pneumonitis on screening chest CT-scan. History of radiation pneumonitis in radiation field (fibrosis) is permitted, as long as it is asymptomatic and no steroids are needed.
Myopathy or any clinical situation that causes significant and persistent elevation of CPK (>2.5 x upper limit of normal (ULN) in two different determinations performed one week apart).
Any diagnosis of autoimmune disease (confirmed by medical records or appropriate laboratory testing) is not allowed.
Has an active infection requiring systemic therapy.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
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 pre-screening or screening visit through 120 days after the last dose of trial treatment.
Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
Has received a live vaccine within 30 days of start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
Patients who had a prior Grade ≥3 immune-related adverse event (e.g. pneumonitis, hepatitis, colitis, endocrinopathy) with prior immunotherapy (e.g. cancer vaccine, cytokine, etc.).
Patients must not be pregnant or nursing due to risk of fetal or nursing infant harm. WOCBP must have agreed to use an effective contraceptive method.
Participants with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
Participants who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Advent Health - Celebration
Kissimmee, Florida, 34747
Moffitt Cancer Center
Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Activity and Enhancement of Immune Checkpoint Inhibition With Lurbinectedin in Relapsed/Recurrent Small Cell Lung Cancer (SCLC)

Read the detailed description

Study was originally designed as a Phase I/II but was terminated during the Phase I portion due to dose limiting toxicities.

Conditions: Small-cell Lung Cancer, Relapsed Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer
Being tested: Nivolumab, Ipilimumab, Lurbinectedin
Medical subject headings: Small Cell Lung Carcinoma

What participants receive

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

NivolumabDrug
Also called Opdivo
Participants will receive 1 mg/kg Nivolumab on Day 1 of each treatment cycle for 4 cycles (induction immunotherapy). After 4 treatment cycles, Nivolumab will be continued at a flat dose of 360 mg.
IpilimumabDrug
Also called Yervoy
Participants will receive 3mg/kg Ipilimumab on Day 1 of each treatment cycle for 4 cycles (induction immunotherapy). After 4 cycles, Ipilimumab will be discontinued.
LurbinectedinDrug
Participants will be treated at 1 of 3 dose levels of Lurbinectedin, beginning at 1.5 mg/m^2 and increasing to 3.2 mg/m^2 or the Maximum Tolerated Dose (MTD)

Study groups in NCT04610658
Study group	Role	What they receive
Phase 1 Dose Level 1: Nivolumab and Ipilimumab plus Lurbinectedin	Experimental	Participants will be treated at dose level 1: nivolumab 1mg/kg, ipilimumab 3mg/kg plus 1.5 mg/m^2 lurbinectedin. Participants will receive nivolumab, ipilimumab and Lurbinectedin every 3 weeks for 4 cycles. After 4 treatment cycles, ipilimumab will be discontinued and participants will continue treatment with a flat dose of 360 mg nivolumab and Lurbinectedin at dose level 1 every 3 weeks. Receives: Drug: Nivolumab; Drug: Ipilimumab; Drug: Lurbinectedin
Phase 1 Dose Level 2: Nivolumab and Ipilimumab plus Lurbinectedin	Experimental	Participants will be treated at dose level 2: nivolumab 1mg/kg, ipilimumab 3mg/kg plus 2.6 mg/m^2 lurbinectedin. Participants will receive nivolumab, ipilimumab and Lurbinectedin every 3 weeks for 4 cycles. After 4 treatment cycles, ipilimumab will be discontinued and participants will continue treatment with a flat dose of 360 mg nivolumab and Lurbinectedin at dose level 2 every 3 weeks. Receives: Drug: Nivolumab; Drug: Ipilimumab; Drug: Lurbinectedin
Phase 1 Dose Level 3: Nivolumab and Ipilimumab plus Lurbinectedin	Experimental	Participants will be treated at dose level 3: nivolumab 1mg/kg, ipilimumab 3mg/kg plus 3.2 mg/m^2 lurbinectedin. Participants will receive nivolumab, ipilimumab and Lurbinectedin every 3 weeks for 4 cycles. After 4 treatment cycles, ipilimumab will be discontinued and participants will continue treatment with a flat dose of 360 mg nivolumab and Lurbinectedin at dose level 3 every 3 weeks. Receives: Drug: Nivolumab; Drug: Ipilimumab; Drug: Lurbinectedin

What is being measured

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

Phase 1: Maximum Tolerated Dose (MTD) of Lurbinectedin with Nivolumab and Ipilimumab
Maximum tolerated Dose will be determined by testing increasing doses of Lurbinectedin along with fixed doses of Nivolumab and Ipilimumab.
Measured: Up to 12 weeks per cohort
Phase II: Disease Control Rate
Disease Control Rate (DCR) is defined as Complete Response (CR) +Partial Response (PR) +Stable Disease (SD). Best response time will be used for this measurement.
Measured: Up to 12 months

Secondary outcomes (3)

Overall Response Rate
Overall Response Rate is defined as Complete Response + Partial Response using RECIST v1.1 criteria.
Measured: Up to 12 months
Progression Free Survival
Progression Free Survival is defined as the time from enrollment to date of progression or death, or censor at last clinical follow-up date.
Measured: Up to 12 months
Overall Survival
Overall Survival is defined as the time from study enrollment to death from any cause.
Measured: Up to 12 months

Timeline

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

23 Nov 202024 Mar 2023

First posted30 Oct 2020
Study start23 Nov 2020
Primary completion24 Mar 2023
Study completion24 Mar 2023

Why it stopped: DLTs

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.
More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04610658
Sponsor's protocol ID: MCC-20332
Status last verified: Apr 2024
First submitted: 26 Oct 2020
Last updated: 2 Apr 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Activity and Enhancement of Immune Checkpoint Inhibition With Lurbinectedin in Relapsed/Recurrent Small Cell Lung Cancer (SCLC)
ClinicalTrials.gov ID: NCT04610658
Acronym / sponsor ID: MCC-20332
Conditions: Small-cell Lung Cancer, Relapsed Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: DLTs
Enrolment: 9 participants (actual)
Lead sponsor: H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
Collaborators: Bristol-Myers Squibb, Jazz Pharmaceuticals
Study start: 23 Nov 2020 (actual)
Primary completion: 24 Mar 2023 (actual)
Study completion: 24 Mar 2023 (actual)
First posted: 30 Oct 2020 (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.

Detailed description

Study was originally designed as a Phase I/II but was terminated during the Phase I portion due to dose limiting toxicities.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Phase 1 Dose Level 1: Nivolumab and Ipilimumab plus Lurbinectedin	Experimental	Drug: Nivolumab, Drug: Ipilimumab, Drug: LurbinectedinParticipants will be treated at dose level 1: nivolumab 1mg/kg, ipilimumab 3mg/kg plus 1.5 mg/m^2 lurbinectedin. Participants will receive nivolumab, ipilimumab and Lurbinectedin every 3 weeks for 4 cycles. After 4 treatment cycles, ipilimumab will be discontinued and participants will continue treatment with a flat dose of 360 mg nivolumab and Lurbinectedin at dose level 1 every 3 weeks.
Phase 1 Dose Level 2: Nivolumab and Ipilimumab plus Lurbinectedin	Experimental	Drug: Nivolumab, Drug: Ipilimumab, Drug: LurbinectedinParticipants will be treated at dose level 2: nivolumab 1mg/kg, ipilimumab 3mg/kg plus 2.6 mg/m^2 lurbinectedin. Participants will receive nivolumab, ipilimumab and Lurbinectedin every 3 weeks for 4 cycles. After 4 treatment cycles, ipilimumab will be discontinued and participants will continue treatment with a flat dose of 360 mg nivolumab and Lurbinectedin at dose level 2 every 3 weeks.
Phase 1 Dose Level 3: Nivolumab and Ipilimumab plus Lurbinectedin	Experimental	Drug: Nivolumab, Drug: Ipilimumab, Drug: LurbinectedinParticipants will be treated at dose level 3: nivolumab 1mg/kg, ipilimumab 3mg/kg plus 3.2 mg/m^2 lurbinectedin. Participants will receive nivolumab, ipilimumab and Lurbinectedin every 3 weeks for 4 cycles. After 4 treatment cycles, ipilimumab will be discontinued and participants will continue treatment with a flat dose of 360 mg nivolumab and Lurbinectedin at dose level 3 every 3 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Measurable disease based on RECIST v1.1
Performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
Adequate organ function as defined per protocol
Women of child bearing potential (WOCBP) must have a negative urine or serum pregnancy test within 72 hours from receiving first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
WOCBP should agree to use 2 methods of birth control or abstain from heterosexual activity for the course of the study through 5 months after the last dose of study medication, or should be surgically sterile. Note: A woman is considered to be of "reproductive potential" (WOCBP) if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures, she is responsible for beginning contraceptive measures.

Key exclusion criteria (25 listed)

Individuals meeting any of the following criteria will be excluded from participation in this study:
Is currently participating in a study of an investigational agent or device and received or used the investigational agent or device within 4 weeks of the first dose of treatment.
Has a diagnosis of immunodeficiency or is receiving systemic steroid or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment. Note: Systemic steroid doses of ≤ 10 mg of prednisone daily or its equivalent are allowed in patients receiving physiologic replacement steroid doses
Has a known history of active Bacillus Tuberculosis (TB)
Hypersensitivity to Lurbinectedin, Ipilimumab and/or nivolumab or any of its excipients.

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: OpdivoParticipants will receive 1 mg/kg Nivolumab on Day 1 of each treatment cycle for 4 cycles (induction immunotherapy). After 4 treatment cycles, Nivolumab will be continued at a flat dose of 360 mg.	Drug	Phase 1 Dose Level 1: Nivolumab and Ipilimumab plus Lurbinectedin, Phase 1 Dose Level 2: Nivolumab and Ipilimumab plus Lurbinectedin, Phase 1 Dose Level 3: Nivolumab and Ipilimumab plus Lurbinectedin
IpilimumabAlso: YervoyParticipants will receive 3mg/kg Ipilimumab on Day 1 of each treatment cycle for 4 cycles (induction immunotherapy). After 4 cycles, Ipilimumab will be discontinued.	Drug	Phase 1 Dose Level 1: Nivolumab and Ipilimumab plus Lurbinectedin, Phase 1 Dose Level 2: Nivolumab and Ipilimumab plus Lurbinectedin, Phase 1 Dose Level 3: Nivolumab and Ipilimumab plus Lurbinectedin
LurbinectedinParticipants will be treated at 1 of 3 dose levels of Lurbinectedin, beginning at 1.5 mg/m^2 and increasing to 3.2 mg/m^2 or the Maximum Tolerated Dose (MTD)	Drug	Phase 1 Dose Level 1: Nivolumab and Ipilimumab plus Lurbinectedin, Phase 1 Dose Level 2: Nivolumab and Ipilimumab plus Lurbinectedin, Phase 1 Dose Level 3: Nivolumab and Ipilimumab plus Lurbinectedin

Primary outcome

Phase 1: Maximum Tolerated Dose (MTD) of Lurbinectedin with Nivolumab and Ipilimumab
Time frame: Up to 12 weeks per cohort
Maximum tolerated Dose will be determined by testing increasing doses of Lurbinectedin along with fixed doses of Nivolumab and Ipilimumab.
Phase II: Disease Control Rate
Time frame: Up to 12 months
Disease Control Rate (DCR) is defined as Complete Response (CR) +Partial Response (PR) +Stable Disease (SD). Best response time will be used for this measurement.

3 secondary outcomes

Overall Response Rate
Time frame: Up to 12 months
Progression Free Survival
Time frame: Up to 12 months
Overall Survival
Time frame: Up to 12 months

Results and safety

The study was stopped early (reason given: DLTs). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
Individual participant dataSharing planned: Undecided

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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.

Alberto A Chiappori, MD principal investigator

Moffitt Cancer Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 25 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 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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: DLTs). 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?

Phase 1: Maximum Tolerated Dose (MTD) of Lurbinectedin with Nivolumab and Ipilimumab (time frame: Up to 12 weeks per cohort). The study lists 2 primary outcomes in all. 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 NCT04610658.

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 2 Apr 2024.