A Phase 3 interventional study of Pembrolizumab and Ipilimumab in Carcinoma, Non-Small-Cell Lung, sponsored by Merck Sharp & Dohme LLC. Completed at 187 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 46 studies testing ipilimumab in Carcinoma, Non-Small-Cell Lung — 6 open to participants now, 12 under way, none of them phase 3. Ipilimumab · Carcinoma, Non-Small-Cell Lung.
Among the 46 studies testing ipilimumab in Carcinoma, Non-Small-Cell Lung, this one is the 4th largest by enrollment, is one of 11 that started in 2017, is one of 10 in phase 3, and was the 24th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →6 of the 46 studies testing ipilimumab in Carcinoma, Non-Small-Cell Lung are open now, in 3 countries. Recruiting first, the newest first:
Washington University School of Medicine · Sites in United States
Ages 18+
The First Affiliated Hospital of Guangzhou Medical University · Sites in China
Ages 18–80
University of Alabama at Birmingham · Sites in United States
Ages 18–89
Second Affiliated Hospital of Guangzhou Medical University · Sites in China
Ages 18–75
Brown University · Sites in United States
Ages 18+
By country, each count listing its studies:
Ipilimumab: first FDA approval 2011 (YERVOY), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, ipilimumab is the treatment under test here. Read study by study →
46 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 29 · Phase 3 10
First in 2002; this study’s year is marked. 11 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 568 is above the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 38 across the 46 interventional studies. Of the 31 that completed or were terminated, 23 (74%) have results posted.
This tab as a report to print or save as PDF → With an account.
14 of 46 have an industry lead sponsor. The 10 most frequent:
This study is registered under Merck Sharp & Dohme LLC, one of the names counted as Merck & Co., Inc. Under that name alone:
Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.
Of its 503 completed or terminated interventional studies of FDA-regulated products, 371 (74%) have results posted.
91 studies in Carcinoma, Non-Small-Cell Lung by Merck & Co., Inc: 14 open now, 26 under way, 18 of them phase 3. Of 65 finished, 49 (75%) have results posted.
Among the 91 studies in Carcinoma, Non-Small-Cell Lung by Merck & Co., Inc, this one is the 20th largest by enrollment of the 88 interventional ones that give a count, is one of 2 that started in 2017, is one of 38 in phase 3, and was the 41st registered.
Merck & Co., Inc’s Carcinoma, Non-Small-Cell Lung studies by the year they started, since 2000.
3 of the studies testing ipilimumab in Carcinoma, Non-Small-Cell Lung that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05597800Universita di VeronaNivolumab/Ipilimumab and Chemotherapy Combination in Advanced NSCLC Patients With HIV, HBV, HCV and Long Covid Syndrome | 2026-12-31 |
| NCT06364917University of Alabama at BirminghamDISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLC | 2027-04-27 |
| NCT05012254Fundación GECPNivolumab and Ipilimumab Plus Chemotherapy for Patients With Stage IV Lung Cancer With Brain Metastases | 2027-10-15 |
Add all 3 to your calendar (.ics) → With an account.
Among the 46 studies testing ipilimumab in Carcinoma, Non-Small-Cell Lung, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Merck & Co., Inc’s 91 in Carcinoma, Non-Small-Cell Lung:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo.
With Amendment 6 (effective date: 11-Dec-2020), active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded. Participants will discontinue ipilimumab and placebo and participants who remain on treatment will receive open-label pembrolizumab only.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment.
Biological: Pembrolizumab · Biological: Ipilimumab
Participants receive 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment.
Biological: Pembrolizumab · Other: Placebo
Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
Also known as: KEYTRUDA®, MK-3475
Administered as an IV infusion every 6 weeks (Q6W)
Also known as: YERVOY®
Normal saline solution administered as an IV infusion Q6W
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of analysis were censored at the date of last known contact. The median survival (in months) and the associated 95% confidence intervals (CIs) were reported using Kaplan-Meier method was used. Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and predominant tumor history (squamous versus non-squamous) was used to estimate hazard ratio (HR) and 95% CIs for first course study treatment per protocol.
Time frame: Up to approximately 32 months (through data cut-off date: 01 Sep 2020)
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR)
PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in sum of diameters of target lesions. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The median survival (in months) and associated 95% CIs were reported using Kaplan-Meier method. Cox regression model with Efron's method of tie handling with treatment as covariate stratified by ECOG performance status (0 vs. 1), geographic region of the enrolling site (East Asia vs. non-East Asia), and predominant tumor history (squamous vs. non-squamous) was used to estimate HR and 95% CIs for first course study treatment per protocol.
Time frame: Up to approximately 32 months (through data cut-off date 01 Sep 2020)
Objective Response Rate (ORR) Per RECIST 1.1 Based on BICR
ORR was defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by BICR. In this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Per protocol the ORR was calculated using the Miettinen \& Nurminen method stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and predominant tumor history (squamous versus non-squamous) for the first course of study treatment.
Time frame: Up to approximately 32 months (data cut-off date 01 Sep 2020)
Duration of Response (DOR) Per RECIST 1.1 Based on BICR
For participants who demonstrated a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. Per protocol, the DOR for all participants who experienced a CR or PR was presented for the first course of study treatment.
Time frame: Up to approximately 32 months (data cut-off date 01 Sep 2020)
Time to True Deterioration (TTD) in Cough, Pain in Chest, and Shortness of Breath
TTD was defined as the time to the first onset of a 10-point or greater score deterioration from baseline in any one of the 3 symptoms (cough, pain in chest or shortness of breath), confirmed by a second adjacent 10-point or greater score deterioration from baseline. Cough was based on EORTC QLQ-LC13 question 1, pain in chest was based on EORTC QLQ-LC13 question 10, and shortness of breath was based on EORTC QLQ-C30 question 8. Per protocol, TTD was reported for first course study treatment.
Time frame: Up to approximately 32 months (data cut-off date 01 Sep 2020)
Number of Participants Who Experienced an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Per protocol, the number of participants who experienced an AE were reported for the first course of study treatment and follow up.
Time frame: Up to approximately 27 months
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Per protocol, the number of participants who discontinued study treatment due to an AE were reported for the first course of study treatment.
Time frame: Up to approximately 24 months
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Scale Score to Week 18
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. Per protocol, the change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score were presented for first course study treatment.
Time frame: Baseline, Week 18
| Milestone | Pembrolizumab + Ipilimumab | Pembrolizumab + Placebo |
|---|---|---|
| Started | 284 | 284 |
| Completed | 0 | 0 |
| Not completed | 284 | 284 |
| Withdrew: Death | 191 | 192 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Sponsor decision | 90 | 89 |
| Withdrew: Laryngeal carcinoma | 0 | 1 |
| Withdrew: Not reported | 1 | 0 |
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of analysis were censored at the date of last known contact. The median survival (in months) and the associated 95% confidence intervals (CIs) were reported using Kaplan-Meier method was used. Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and predominant tumor history (squamous versus non-squamous) was used to estimate hazard ratio (HR) and 95% CIs for first course study treatment per protocol.
| Months | Pembrolizumab + Ipilimumab | Pembrolizumab + Placebo |
|---|---|---|
| Overall Survival (OS) | 21.4 (16.6 to NA) | 21.9 (18.0 to NA) |
PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in sum of diameters of target lesions. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The median survival (in months) and associated 95% CIs were reported using Kaplan-Meier method. Cox regression model with Efron's method of tie handling with treatment as covariate stratified by ECOG performance status (0 vs. 1), geographic region of the enrolling site (East Asia vs. non-East Asia), and predominant tumor history (squamous vs. non-squamous) was used to estimate HR and 95% CIs for first course study treatment per protocol.
| Months | Pembrolizumab + Ipilimumab | Pembrolizumab + Placebo |
|---|---|---|
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) | 8.2 (6.0 to 10.5) | 8.4 (6.3 to 10.5) |
ORR was defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by BICR. In this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Per protocol the ORR was calculated using the Miettinen \& Nurminen method stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and predominant tumor history (squamous versus non-squamous) for the first course of study treatment.
| Percentage of Participants | Pembrolizumab + Ipilimumab | Pembrolizumab + Placebo |
|---|---|---|
| Objective Response Rate (ORR) Per RECIST 1.1 Based on BICR | 45.4 (39.5 to 51.4) | 45.4 (39.5 to 51.4) |
For participants who demonstrated a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. Per protocol, the DOR for all participants who experienced a CR or PR was presented for the first course of study treatment.
| Months | Pembrolizumab + Ipilimumab | Pembrolizumab + Placebo |
|---|---|---|
| Duration of Response (DOR) Per RECIST 1.1 Based on BICR | 16.1 (12.7 to 26) | 17.3 (14.8 to NA) |
TTD was defined as the time to the first onset of a 10-point or greater score deterioration from baseline in any one of the 3 symptoms (cough, pain in chest or shortness of breath), confirmed by a second adjacent 10-point or greater score deterioration from baseline. Cough was based on EORTC QLQ-LC13 question 1, pain in chest was based on EORTC QLQ-LC13 question 10, and shortness of breath was based on EORTC QLQ-C30 question 8. Per protocol, TTD was reported for first course study treatment.
| Months | Pembrolizumab + Ipilimumab | Pembrolizumab + Placebo |
|---|---|---|
| Time to True Deterioration (TTD) in Cough, Pain in Chest, and Shortness of Breath | NA (12.9778 to NA) | 20.0416 (12.7149 to NA) |
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Per protocol, the number of participants who experienced an AE were reported for the first course of study treatment and follow up.
| Participants | Pembrolizumab + Ipilimumab | Pembrolizumab + Placebo |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event (AE) | 272 | 263 |
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Per protocol, the number of participants who discontinued study treatment due to an AE were reported for the first course of study treatment.
| Participants | Pembrolizumab + Ipilimumab | Pembrolizumab + Placebo |
|---|---|---|
| Number of Participants Who Discontinued Study Treatment Due to an AE | 105 | 57 |
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. Per protocol, the change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score were presented for first course study treatment.
| Score on a scale | Pembrolizumab + Ipilimumab | Pembrolizumab + Placebo |
|---|---|---|
| Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Scale Score to Week 18 | 3.72 (0.91 to 6.53) | 4.14 (1.42 to 6.86) |
Collected over Up to approximately 56 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembrolizumab+Ipilimumab (First Course) | 191/284 (67.3%) | 146/282 (51.8%) | 251/282 (89%) |
| Pembrolizumab+Placebo (First Course) | 188/284 (66.2%) | 114/281 (40.6%) | 232/281 (82.6%) |
| Pembrolizumab + Placebo (Second Course) | 4/18 (22.2%) | 4/18 (22.2%) | 10/18 (55.6%) |
| Event | Pembrolizumab+Ipilimumab (First Course) | Pembrolizumab+Placebo (First Course) | Pembrolizumab + Placebo (Second Course) |
|---|---|---|---|
| Cerebrovascular accidentNervous system disorders | 0/282 | 1/281 | 2/18 |
| PneumoniaInfections and infestations | 21/282 | 20/281 | 0/18 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 20/282 | 10/281 | 0/18 |
| Cardiac tamponadeCardiac disorders | 0/282 | 1/281 | 1/18 |
| COVID-19 pneumoniaInfections and infestations | 0/282 | 0/281 | 1/18 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 5/282 | 10/281 | 0/18 |
| ColitisGastrointestinal disorders | 7/282 | 1/281 | 0/18 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 4/282 | 6/281 | 0/18 |
| DiarrhoeaGastrointestinal disorders | 6/282 | 1/281 | 0/18 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 5/282 | 5/281 | 0/18 |
| Event | Pembrolizumab+Ipilimumab (First Course) | Pembrolizumab+Placebo (First Course) | Pembrolizumab + Placebo (Second Course) |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 70/282 | 46/281 | 1/18 |
| PruritusSkin and subcutaneous tissue disorders | 69/282 | 58/281 | 0/18 |
| Decreased appetiteMetabolism and nutrition disorders | 61/282 | 39/281 | 0/18 |
| CoughRespiratory, thoracic and mediastinal disorders | 47/282 | 58/281 | 1/18 |
| RashSkin and subcutaneous tissue disorders | 57/282 | 45/281 | 0/18 |
| ConstipationGastrointestinal disorders | 39/282 | 52/281 | 0/18 |
| NauseaGastrointestinal disorders | 51/282 | 40/281 | 0/18 |
| AstheniaGeneral disorders | 51/282 | 44/281 | 0/18 |
| FatigueGeneral disorders | 47/282 | 50/281 | 1/18 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 39/282 | 45/281 | 1/18 |
All randomized participants.
| Age, Continuous(Years) | Pembrolizumab + Ipilimumab | Pembrolizumab + Placebo | Total |
|---|---|---|---|
| Mean | 63.7 ± 9.3 | 64.5 ± 8.8 | 64.1 ± 9.1 |
| Sex/Gender, Customized(Participants) | Pembrolizumab + Ipilimumab | Pembrolizumab + Placebo | Total |
|---|---|---|---|
| Male | 202 | 191 | 393 |
| Female | 82 | 92 | 174 |
| Undifferentiated | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Pembrolizumab + Ipilimumab | Pembrolizumab + Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 54 | 37 | 91 |
| Not Hispanic or Latino | 208 | 225 | 433 |
| Unknown or Not Reported | 22 | 22 | 44 |
| Race (NIH/OMB)(Participants) | Pembrolizumab + Ipilimumab | Pembrolizumab + Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 4 | 3 | 7 |
| Asian | 33 | 31 | 64 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 218 | 223 | 441 |
| More than one race | 6 | 5 | 11 |
| Unknown or Not Reported | 22 | 22 | 44 |
| Eastern Cooperative Oncology Group (ECOG) performance status(Participants) | Pembrolizumab + Ipilimumab | Pembrolizumab + Placebo | Total |
|---|---|---|---|
| 0 = Fully active; no performance restrictions | 101 | 104 | 205 |
| 1 = Strenuous physical activity restricted; fully ambulatory & able to carry out light work | 183 | 180 | 363 |
| Tumor histology(Participants) | Pembrolizumab + Ipilimumab | Pembrolizumab + Placebo | Total |
|---|---|---|---|
| Squamous | 77 | 81 | 158 |
| Non squamous | 207 | 203 | 410 |
| Geographic region(Participants) | Pembrolizumab + Ipilimumab | Pembrolizumab + Placebo | Total |
|---|---|---|---|
| East Asia | 32 | 31 | 63 |
| Non-East Asia | 252 | 253 | 505 |
Showing the first 100 of 187 sites across 24 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pd
Data sharing details ↗ · engagezone.msd.com
Ran from Dec 2017 to primary completion in Sep 2020, 32 months.
Results were first posted in Sep 2021, 1 year after primary completion.
Of 315 industry-sponsored phase 3 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 57. This study's 32 months is below that.
Counting every sponsor, half of 424 studies reached it within 45 months; a quarter within 30 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ipilimumab
Carcinoma, Non-Small-Cell Lung →