Non-small Cell Lung CancerPhase 2NCT03425331
Biomarkers of Response to Ipilimumab and Nivolumab in First-line NSCLC
A Phase 2 study testing Ipilimumab and Nivolumab in people with Non-small Cell Lung Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
This research study is studying two immunotherapy drugs as a possible treatment for advanced non-small cell lung cancer (NSCLC). The drugs involved in this study are: Ipilimumab Nivolumab Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Ipilimumab and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Apr 2018to 28 Nov 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically confirmed stage IV NSCLC, with no prior systemic anti-cancer therapy of any kind (including EGFR and ALK inhibitors). Prior definitive chemoradiation for locally advanced disease is permitted as long as the last administration of chemotherapy or radiation (whichever was given last) occurred at least 6 months prior to enrollment. Prior adjuvant or neoadjuvant chemotherapy for early stage lung cancer is permitted if completed at least 6 months prior to initiating study treatment.
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
- Age ≥ 18 years.
- ECOG performance status ≤ 1 (see Appendix A)
- Participants must have normal organ and marrow function as defined below:
- Absolute neutrophil count ≥ 1,500/mcL
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- Platelets ≥ 100,000/mcL
- Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN, OR
- AST(SGOT)/ALT(SGPT) ≤ 5 × institutional ULN if liver metastases are present
- Serum creatinine ≤ 1.5 × institutional ULN, OR
- Creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with serum creatinine levels above 1.5 × institutional ULN.
- Ability to understand and the willingness to sign a written informed consent document.
- Participants must have a tumor tissue sample available (formalin-fixed paraffin embedded [FFPE] tissue block or unstained slides); may be newly obtained or obtained within 6 months prior to enrollment (without systemic therapy given after the sample was obtained). Participants without sufficient archival tissue may be enrolled following successful completion of the pre-treatment tumor tissue biopsy. Tissue must be a core needle biopsy, excisional, or incisional biopsy. Fine needle aspirates (FNA) or malignant effusions are not adequate. Bone biopsies without a soft tissue component are not adequate.
- The effects of nivolumab and ipilimumab on the developing human fetus are unknown. For this reason, women of childbearing potential (WOCBP) must agree to follow instructions for acceptable contraception from the time of signing consent, and for 23 weeks after their last dose of protocol-indicated treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol who are not azoospermic who are sexually active with WOCBP must agree to follow instructions for acceptable contraception from the time of signing consent, and for 31 weeks after their last dose of protocol-indicated treatment.
- Participants must be able and willing to undergo a pre-treatment tumor tissue biopsy. Participants must also be willing to undergo an on-treatment tumor tissue biopsy if clinically feasible.
Who cannot join
- Participants with known EGFR mutations or ALK rearrangements. All subjects must have been tested for EGFR mutation and ALK rearrangement prior to study entry, unless they are known to have a KRAS mutation.
- Participants who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Participants who received prior non-CNS directed palliative radiation therapy within 7 days of the date of study entry.
- Participants who are receiving any other investigational agents.
- Participants with known untreated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to study entry. Subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to first study treatment.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ipilimumab or nivolumab.
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- Participants with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to first treatment and no additional therapy is required or anticipated to be required during the study period as judged by the treating investigator. Exceptions include non-melanoma skin cancers, and in situ cancers of any type (e.g. bladder, gastric, colon, cervical/dysplasia, melanoma, or breast carcinoma in situ).
- Participants with any other active malignancy requiring concurrent intervention.
- Participants with an active, known, or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Participants with a condition requiring systemic treatment with corticosteroids of > 10 mg daily prednisone (or equivalent), or subjects requiring other immunosuppressive medications within 14 days of first treatment. Inhaled, topical, ophthalmologic, local steroid injections, and adrenal replacement steroid > 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease.
- Participants with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity in the opinion of the treating investigator.
- Participants with a known history of testing positive for human immunodeficiency virus (HIV), or known acquired immunodeficiency syndrome (AIDS).
- Participants with known positive test for hepatitis B or C indicating acute or chronic infection.
- Participants with ≥ Grade 2 peripheral neuropathy.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because ipilimumab and nivolumab are both agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ipilimumab or nivolumab, breastfeeding should be discontinued if the mother is treated with ipilimumab or nivolumab. A negative serum pregnancy test is required prior to study entry.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02214
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Biomarkers of Response to Ipilimumab and Nivolumab as First-line Therapy for Metastatic Non-small Cell Lung Cancer (NSCLC): an Open-label, Single Arm Phase 2 Study
This research study is studying two immunotherapy drugs as a possible treatment for advanced non-small cell lung cancer (NSCLC).
The drugs involved in this study are:
- Ipilimumab
- Nivolumab
Read the detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of investigational drugs to learn whether the drugs work in treating a specific disease. "Investigational" means that the drugs are being studied.
The FDA (the U.S. Food and Drug Administration) has not approved ipilimumab for this specific disease but it has been approved for other uses, including for patients with advanced melanoma.
The FDA (the U.S. Food and Drug Administration) has approved nivolumab as a treatment option for this disease. However, nivolumab it is not approved in combination with ipilimumab to treat NSCLC.
Nivolumab and ipilimumab are both types of immunotherapy. Immunotherapy works by stimulating the body's own immune system to attack cancer cells. The combination of ipilimumab with nivolumab may or may not increase anti-cancer activity by further boosting the immune system.
In this research study, the investigators are investigating if the combination of ipilimumab and nivolumab is effective in treating advanced NSCLC. The investigators are also investigating whether there are certain DNA or protein markers in the blood or tumor tissue that may indicate whether the combination will work in future patients.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Ipilimumab, Nivolumab
- Keywords
- Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
Also called Yervoy
Ipilimumab is a type of immunotherapy. Immunotherapy works by stimulating the body's own immune system to attack cancer cells
NivolumabDrug
Also called Opdivo
Nivolumab is a type of immunotherapy. Immunotherapy works by stimulating the body's own immune system to attack cancer cells
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab+Ipilimumab | Experimental | Nivolumab will be administered once every 2 weeks 1 mg/kg intravenously Ipilimumab will be administered once every 6 weeks 3 mg/kg intravenously Receives: Drug: Ipilimumab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Response
Best response on treatment is based on RECISTv1.1 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Both require confirmation no fewer than 4 weeks apart. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and the sum must also demonstrate an absolute increase of at least 5 mm since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease (SD) is defined as any condition not meeting the above criteria.
Measured: Disease was evaluated radiologically at baseline and then every 6 weeks for the first 6 cycles of therapy. Median treatment duration for this study cohort is 8.05 months with range (2.76 months - 15.90 months).
Secondary outcomes (4)
Median Progression-free Survival (PFS)
PFS based on the Kaplan-Meier method is defined as the duration between registration and documented disease progression (PD) defined per RECIST 1.1 criteria or death, or is censored at time of last disease assessment.
Measured: Disease was evaluated at baseline and then every 6 weeks for the first 6 cycles of therapy and in long-term follow-up every 3 months. Median follow-up for survival is of 15.97 months with range (4.00 months - 20.63 months).
Median Overall Survival (OS)
OS based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.
Measured: Median follow-up for survival is of 15.97 months with range (4.00 months - 20.63 months).
Median Duration of Response (DOR)
DOR, estimated using the Kaplan Meier method, is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) per RECISTv1.1, until the first date that recurrent or progressive disease is objectively documented. Patients without PD are censored at the date of last disease assessment.
Measured: Disease was evaluated radiologically at baseline and then every 6 weeks for the first 6 cycles of therapy. Median treatment duration for this study cohort is 8.05 months with range (2.76 months - 15.90 months).
Incidence of Grade 4-5 Treatment-related Toxicity Rate
All grade 4-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 that are not resolved in accordance with treatment guidelines were counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation.
Measured: AE evaluated on day 1, 15, 29 each cycle. The median of treatment duration is 8.05 months with range (2.76 months - 15.90 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start10 Apr 2018
- Primary completion18 May 2020
- Study completion28 Nov 2021
Why it stopped: Slow accrual, competing studies, and lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Biagio Ricciuti, Dana-Farber Cancer Institute
- Investigators
- Mark Awad, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425331
- Sponsor's protocol ID
- 17-566
- Status last verified
- Dec 2025
- First submitted
- 1 Feb 2018
- Last updated
- 16 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Response to Ipilimumab and Nivolumab as First-line Therapy for Metastatic Non-small Cell Lung Cancer (NSCLC): an Open-label, Single Arm Phase 2 Study
- ClinicalTrials.gov ID
- NCT03425331
- Acronym / sponsor ID
- 17-566
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual, competing studies, and lack of efficacy
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 28 Nov 2021 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Posted 22 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is studying two immunotherapy drugs as a possible treatment for advanced non-small cell lung cancer (NSCLC).
The drugs involved in this study are:
- Ipilimumab
- Nivolumab
Detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of investigational drugs to learn whether the drugs work in treating a specific disease. "Investigational" means that the drugs are being studied.
The FDA (the U.S. Food and Drug Administration) has not approved ipilimumab for this specific disease but it has been approved for other uses, including for patients with advanced melanoma.
The FDA (the U.S. Food and Drug Administration) has approved nivolumab as a treatment option for this disease. However, nivolumab it is not approved in combination with ipilimumab to treat NSCLC.
Nivolumab and ipilimumab are both types of immunotherapy. Immunotherapy works by stimulating the body's own immune system to attack cancer cells. The combination of ipilimumab with nivolumab may or may not increase anti-cancer activity by further boosting the immune system.
In this research study, the investigators are investigating if the combination of ipilimumab and nivolumab is effective in treating advanced NSCLC. The investigators are also investigating whether there are certain DNA or protein markers in the blood or tumor tissue that may indicate whether the combination will work in future patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nivolumab+Ipilimumab | Experimental | Drug: Ipilimumab, Drug: NivolumabNivolumab will be administered once every 2 weeks 1 mg/kg intravenously Ipilimumab will be administered once every 6 weeks 3 mg/kg intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed stage IV NSCLC, with no prior systemic anti-cancer therapy of any kind (including EGFR and ALK inhibitors). Prior definitive chemoradiation for locally advanced disease is permitted as long as the last administration of chemotherapy or radiation (whichever was given last) occurred at least 6 months prior to enrollment. Prior adjuvant or neoadjuvant chemotherapy for early stage lung cancer is permitted if completed at least 6 months prior to initiating study treatment.
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
- Age ≥ 18 years.
- ECOG performance status ≤ 1 (see Appendix A)
- Participants must have normal organ and marrow function as defined below:
Key exclusion criteria (16 listed)
- Participants with known EGFR mutations or ALK rearrangements. All subjects must have been tested for EGFR mutation and ALK rearrangement prior to study entry, unless they are known to have a KRAS mutation.
- Participants who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Participants who received prior non-CNS directed palliative radiation therapy within 7 days of the date of study entry.
- Participants who are receiving any other investigational agents.
- Participants with known untreated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to study entry. Subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to first study treatment.
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 |
|---|---|---|
| IpilimumabAlso: YervoyIpilimumab is a type of immunotherapy. Immunotherapy works by stimulating the body's own immune system to attack cancer cells | Drug | Nivolumab+Ipilimumab |
| NivolumabAlso: OpdivoNivolumab is a type of immunotherapy. Immunotherapy works by stimulating the body's own immune system to attack cancer cells | Drug | Nivolumab+Ipilimumab |
Primary outcome
Best Response
Time frame: Disease was evaluated radiologically at baseline and then every 6 weeks for the first 6 cycles of therapy. Median treatment duration for this study cohort is 8.05 months with range (2.76 months - 15.90 months).
Best response on treatment is based on RECISTv1.1 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Both require confirmation no fewer than 4 weeks apart. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and the sum must also demonstrate an absolute increase of at least 5 mm since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease (SD) is defined as any condition not meeting the above criteria.
4 secondary outcomes
Median Progression-free Survival (PFS)
Time frame: Disease was evaluated at baseline and then every 6 weeks for the first 6 cycles of therapy and in long-term follow-up every 3 months. Median follow-up for survival is of 15.97 months with range (4.00 months - 20.63 months).
Median Overall Survival (OS)
Time frame: Median follow-up for survival is of 15.97 months with range (4.00 months - 20.63 months).
Median Duration of Response (DOR)
Time frame: Disease was evaluated radiologically at baseline and then every 6 weeks for the first 6 cycles of therapy. Median treatment duration for this study cohort is 8.05 months with range (2.76 months - 15.90 months).
Incidence of Grade 4-5 Treatment-related Toxicity Rate
Time frame: AE evaluated on day 1, 15, 29 each cycle. The median of treatment duration is 8.05 months with range (2.76 months - 15.90 months).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Mark Awad, MD, PhD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipilimumab and Nivolumab in people with Non-small Cell Lung Cancer, run by Dana-Farber Cancer Institute at 3 sites 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 16 inclusion and 16 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 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
Yes. Results are posted in the registry (first posted 22 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Best Response (time frame: Disease was evaluated radiologically at baseline and then every 6 weeks for the first 6 cycles of therapy. Median treatment duration for this study cohort is 8.05 months with range (2.76 months - 15.90 months).). 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 16 Jul 2026.