CClinicalTrials.gg
Sign In
CompletedNCT03797326Updated May 4, 2026Results posted

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)

A Phase 2 interventional study of Pembrolizumab and Lenvatinib in Advanced Solid Tumors, Triple Negative Breast Cancer and Ovarian Cancer, sponsored by Merck Sharp & Dohme LLC. Completed at 88 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
611
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer.

02

Conditions studied

  • Advanced Solid Tumors
  • Triple Negative Breast Cancer
  • Ovarian Cancer
  • Gastric Cancer
  • Colorectal Cancer
  • Glioblastoma
  • Biliary Tract Cancers
  • Pancreatic Cancer

Keywords

  • programmed cell death 1 (PD-1, PD1)
  • programmed cell death ligand 1 (PD-L1, PDL1)
  • programmed cell death ligand 2 (PD-L2, PDL2)
  • tyrosine kinase inhibitor (TKI)
  • multiple TKI
  • Vascular Endothelial Growth Factor Receptor (VEFG)
  • Fibroblast Growth Factor (FGF)
  • Platelet-Derived Growth Factor (PDGF)
03

In context

Triple Negative Breast Neoplasms

1,140 studies on the registry are indexed under Triple Negative Breast Neoplasms; 443 are open to participants now.

This study's enrollment of 611 is above the median of 61 across 982 interventional studies indexed under Triple Negative Breast Neoplasms.

Browse Triple Negative Breast Neoplasms studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Has a histologically or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard systemic therapy has failed in one of the following cohorts: TNBC, Ovarian Cancer, Gastric Cancer, Colorectal Cancer, GBM, BTC (intrahepatic, extrahepatic cholangiocarcinoma and gall bladder cancer; excludes Ampulla of Vater), Pancreatic Cancer
  • Must have progressed on or since the last treatment
  • Has measurable disease per RECIST 1.1 (RANO for the GBM cohort) as assessed by the local site investigator/radiology and confirmed by BICR
  • Has provided a PD-L1 evaluable archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
  • Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib, or refrain from heterosexual intercourse during this period
  • Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib, whichever occurs last
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of study treatment initiation
  • Has adequate organ function

For Triple Negative Breast Cancer Participants:

  • Has received one or 2 prior lines of therapy
  • Has Lactate Dehydrogenase (LDH) \<2.0 x Upper Limit of Normal (ULN)
  • Has locally determined results for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 tumor analyses

For Ovarian Cancer Participants:

- Has primary ovarian cancer and has received 3 prior lines of therapy.

For Gastric Cancer Participants:

- Has received 2 prior lines of therapy. Note: Gastric cancer will include participants with both gastric and gastroesophageal junction (GEJ) adenocarcinoma. Participants with squamous cell carcinoma histology are not eligible

For Colorectal Cancer Participants:

- Has received 2 prior lines of therapy

For GBM Participants:

  • Has failed initial systemic therapy for newly diagnosed GBM
  • Have the following time periods elapsed before the projected start of scheduled study treatment: 1) at least 3 weeks from prior surgical resection, 2) at least 1 week from stereotactic biopsy, 3) at least 6 months from completion of prior radiotherapy, 4) at least 4 weeks (or 5 half-lives, whichever is shorter) from any investigational agent, 5) at least 4 weeks from cytotoxic therapy, 6) at least 6 weeks from antibodies, 7) at least 4 weeks (or 5 half-lives, whichever is shorter) from other antitumor therapies and 1 week for cancer vaccines
  • Be neurologically stable (e.g. without a progression of neurologic symptoms or requiring escalating doses of systemic steroid therapy within last 2 weeks) and clinically stable
  • Has histologically confirmed World Health Organization (WHO) Grade IV GBM
  • Has locally determined result for O\^6-methylguanine-DNA methyltransferase (MGMT) analysis

For Biliary Tract Cancer Participants:

  • Has received 1 prior line of therapy
  • Child-Pugh Score, Class A: well-compensated disease. Child-Pugh Score of 5-6

For Pancreatic Cancer Participants:

  • Has pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma that is metastatic at enrollment
  • Has received one or 2 prior lines of therapy
  • Has received prior therapy with at least 1 (platinum-containing regimen or gemcitabine-containing regimen) but no more than 2 prior systemic therapies for unresectable or metastatic pancreatic cancer

Exclusion criteria

Exclusion Criteria:

  • Has gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib
  • Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment (applies to all cohorts except the ovarian cancer cohort)
  • Has radiographic evidence of encasement or invasion of a major blood vessel or of intratumoral cavitation. Participants with portal vein invasion (Vp4), inferior vena cava, or cardiac involvement based on imaging in the BTC cohort are not eligible for enrollment
  • Has clinical significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment
  • Has significant cardiovascular impairment within 12 months of the first dose of study treatment, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA), or cardiac arrhythmia associated with hemodynamic instability
  • Has a history of arterial thromboembolism within 12 months of start of study treatment
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Has a serious nonhealing wound, ulcer or bone fracture
  • Has had major surgery within 3 weeks prior to first dose of study interventions
  • Has biologic response modifiers therapy (e.g. granulocyte colony-stimulating factor) within 4 weeks before study entry
  • Has preexisting ≥Grade 3 gastrointestinal (GI) or non-gastrointestinal fistula
  • Has received prior therapy with lenvatinib, an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137])
  • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study treatment start
  • If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
  • Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
  • Has received a live vaccine within 30 days prior to the first dose of study treatment
  • Has known intolerance to lenvatinib (and/or any of the excipients)
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
  • Has known active CNS metastases and/or carcinomatous meningitis
  • Has tumors involving the brain stem
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of hepatitis B or known active hepatitis C virus infection
  • Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
  • Has had an allogenic tissue/solid organ transplant (large organ transplants, stem-cell transplant requiring chronic immunosuppressant therapy necessary to prevent graft rejection)

For GBM Participants:

  • Has carcinomatous meningitis
  • Has recurrent tumor greater than 6 cm in maximum diameter
  • Has tumor primarily localized to the brainstem or spinal cord
  • Has presence of multifocal tumor, diffuse leptomeningeal or extracranial disease
  • Has evidence of intratumoral or peritumoral hemorrhage on baseline magnetic resonance imaging (MRI) scan other than those that are grade ≤ 1 and either post-operative or stable on at least 2 consecutive MRI scans
  • Has received Optune® TTFields within 2 weeks of study intervention
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
611 participants (actual)

Study arms

  • Experimental
    Pembrolizumab + Lenvatinib (Arm 1)

    Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) plus lenvatinib 20 mg via oral capsule once a day (QD). Pembrolizumab will be administered for up to 35 cycles (up to 2 years). Lenvatinib will be administered until progressive disease or unacceptable toxicity (up to at least 2 years).

    Biological: Pembrolizumab · Drug: Lenvatinib

  • Experimental
    Lenvatinib Monotherapy (Arm 2)

    Participants receive lenvatinib 24 mg via oral capsule QD, to be administered until progressive disease or unacceptable toxicity (up to at least 2 years).

    Drug: Lenvatinib

Interventions

  • BiologicalPembrolizumab

    Administered as an IV infusion on Day 1 Q3W.

    Also known as: MK-3475, Keytruda®

  • DrugLenvatinib

    Administered orally once a day during each 21-day cycle.

    Also known as: MK-7902, E7080, LENVIMA™

06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator Assessment

    ORR was defined as the percentage of participants who had a best overall response of either Complete Response (CR): Disappearance of all target lesions or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions as assessed by RECIST 1.1. The percentage of participants who experienced a CR or PR as assessed by RECIST 1.1 by investigator assessment was presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.

    Time frame: Up to approximately 66 months

  2. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for Glioblastoma Multiforma [GBM] Only), by Blinded Independent Central Review (BICR)

    ORR was defined as the percentage of participants who had a best overall response of either Complete Response (CR): Disappearance of all target lesions or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions as assessed by RECIST 1.1. For participants with GBM, response was assessed according to RANO criteria whereby ORR was defined as the percentage of participants who had a best overall response of either Complete response (CR): Disappearance of all target lesions or Partial response (PR): sum of products of diameters decreased by ≥50% from baseline value. The percentage of participants who experienced a CR or PR as assessed by RECIST 1.1 or RANO by BICR was presented. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.

    Time frame: Up to approximately 66 months

  3. Number of Participants With One or More Adverse Events (AEs)

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one or more AE is presented.

    Time frame: Up to approximately 66 months

  4. Number of Participants Who Discontinued From Study Treatment Due to an AE

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued from study treatment due to an AE is presented.

    Time frame: Up to approximately 62 months

Secondary outcomes

  1. Disease Control Rate (DCR) Per RECIST 1.1 by Investigator Assessment

    DCR was defined per RECIST 1.1 as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]). Disease Control rate per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.

    Time frame: Up to approximately 66 months

  2. Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR

    DCR was defined per RECIST 1.1 as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm\]). The appearance of one or more new lesions is also considered PD.\]). For participants with GBM, response was assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters \[SPD\] decreased by ≥ 50% from baseline value and SD: SPD \<50% decreased from baseline, but \<25% increased from nadir) and clinical performance status with steroid dose information. The DCR as assessed by BICR is presented.

    Time frame: Up to approximately 66 months

  3. Duration of Response (DOR) Per RECIST 1.1 by Investigator Assessment

    For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (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 progressive disease (PD) or death. Per RECIST 1.1, PD is 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 demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. Duration of response per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.

    Time frame: Up to approximately 66 months

  4. Duration of Response (DOR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR

    For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (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 progressive disease (PD) or death. Per RECIST 1.1, PD is 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 demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. For participants with GBM, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information. DOR assessments were based on blinded central imaging review with confirmation.

    Time frame: Up to approximately 66 months

  5. Progression-Free Survival (PFS) Per RECIST 1.1 by Investigator Assessment

    PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥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 ≥5 mm. The appearance of one or more new lesions was also considered PD. The percentage of participants who experienced PFS per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.

    Time frame: Up to approximately 66 months

  6. Progression-Free Survival (PFS) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR

    PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1 (or RANO for GBM participants), modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥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 ≥5 mm. The appearance of one or more new lesions was also considered PD. For participants with GBM, either radiological progression or clinical deterioration (not attributable to a nontumor-related cause) qualifies as PD. The percentage of participants who experienced PFS per RECIST 1.1 or RANO by BICR is presented. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.

    Time frame: Up to approximately 66 months

  7. Overall Survival (OS)

    OS was defined as the time from the date of study treatment to the date of death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. The OS for all participants is presented.

    Time frame: Up to approximately 66 months

  8. Area Under the Concentration Curve at Steady State (AUCss) of Lenvatinib

    Blood samples were collected at pre-specified timepoints to determine the AUCss in participants receiving Lenvatinib (Lenva) co-administered with Pembrolizumab (Pembro). AUCss was defined as a measure of drug exposure that was calculated as the product of plasma drug concentration and time after drug administration at steady state. AUCss determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Noncompartmental analysis was used to calculate AUC0ss for each participant. Mean and standard deviation of AUCss were calculated for each cohort. As specified in the protocol, pharmacokinetic analysis was not planned or conducted in Cohorts D2 and G.

    Time frame: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose and 2-12 hours post-dose; Cycle 2 Day 1: pre-dose, 0.5-4 hours, and 6-10 hours post-dose (up to approximately 23 days). Each cycle is 21 days.

07

Results

Posted Nov 17, 2025

Participant flow

This study was conducted at 85 centers in 17 countries.

Participant flow — Overall Study
MilestoneCohort A: Triple Negative Breast Cancer (Lenva + Pembro)Cohort B: Ovarian Cancer (Lenva + Pembro)Cohort C: Gastric Cancer (Lenva + Pembro)Cohort D1: Colorectal Cancer (Lenva + Pembro)Cohort D2: Colorectal Cancer (Lenva)Cohort E: Glioblastoma Multiforma (Lenva + Pembro)Cohort F: Biliary Tract Cancer (Lenva + Pembro)Cohort G: Pancreatic Cancer (Lenva + Pembro)
Started313110210732102103103
Treated31319910530101102103
Completed00000000
Not completed313110210732102103103
Withdrew: Lost to follow-up10010000
Withdrew: Withdrawal by subject00130223
Withdrew: Sponsor decision33360332
Withdrew: Death2728959530969798
Withdrew: Enrolled in error00322110

Outcome measures

SecondaryDisease Control Rate (DCR) Per RECIST 1.1 by Investigator Assessment

DCR was defined per RECIST 1.1 as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]). Disease Control rate per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.

Time frame:
Up to approximately 66 months
Reported as:
Number · Percentage of Participants
Disease Control Rate (DCR) Per RECIST 1.1 by Investigator Assessment
Percentage of ParticipantsCohort A: Triple Negative Breast Cancer (Lenva + Pembro)Cohort B: Ovarian Cancer (Lenva + Pembro)
Disease Control Rate (DCR) Per RECIST 1.1 by Investigator Assessment51.6 (33.1 to 69.8)77.4 (58.9 to 90.4)
SecondaryDisease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR

DCR was defined per RECIST 1.1 as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm\]). The appearance of one or more new lesions is also considered PD.\]). For participants with GBM, response was assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters \[SPD\] decreased by ≥ 50% from baseline value and SD: SPD \<50% decreased from baseline, but \<25% increased from nadir) and clinical performance status with steroid dose information. The DCR as assessed by BICR is presented.

Time frame:
Up to approximately 66 months
Reported as:
Number · Percentage of Participants
Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
Percentage of ParticipantsCohort C: Gastric Cancer (Lenva + Pembro)Cohort D1: Colorectal Cancer (Lenva + Pembro)Cohort D2: Colorectal Cancer (Lenva)Cohort E: Glioblastoma Multiforma (Lenva + Pembro)Cohort F: Biliary Tract Cancer (Lenva + Pembro)Cohort G: Pancreatic Cancer (Lenva + Pembro)
Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR53.5 (43.2 to 63.6)52.4 (42.4 to 62.2)56.7 (37.4 to 74.5)57.4 (47.2 to 67.2)64.7 (54.6 to 73.9)37.9 (28.5 to 48.0)
SecondaryDuration of Response (DOR) Per RECIST 1.1 by Investigator Assessment

For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (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 progressive disease (PD) or death. Per RECIST 1.1, PD is 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 demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. Duration of response per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.

Time frame:
Up to approximately 66 months
Reported as:
Median · Months
Duration of Response (DOR) Per RECIST 1.1 by Investigator Assessment
MonthsCohort A: Triple Negative Breast Cancer (Lenva + Pembro)Cohort B: Ovarian Cancer (Lenva + Pembro)
Duration of Response (DOR) Per RECIST 1.1 by Investigator Assessment22.9 (4.2 to NA)15.3 (6.4 to NA)
SecondaryDuration of Response (DOR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR

For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (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 progressive disease (PD) or death. Per RECIST 1.1, PD is 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 demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. For participants with GBM, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information. DOR assessments were based on blinded central imaging review with confirmation.

Time frame:
Up to approximately 66 months
Reported as:
Median · Months
Duration of Response (DOR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
MonthsCohort C: Gastric Cancer (Lenva + Pembro)Cohort D1: Colorectal Cancer (Lenva + Pembro)Cohort D2: Colorectal Cancer (Lenva)Cohort E: Glioblastoma Multiforma (Lenva + Pembro)Cohort F: Biliary Tract Cancer (Lenva + Pembro)Cohort G: Pancreatic Cancer (Lenva + Pembro)
Duration of Response (DOR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR8.3 (4.2 to NA)8.3 (4.2 to 18.5)NA (NA to NA)4.6 (3.2 to 15.6)6.2 (4.2 to 7.1)5.8 (2.7 to NA)
SecondaryProgression-Free Survival (PFS) Per RECIST 1.1 by Investigator Assessment

PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥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 ≥5 mm. The appearance of one or more new lesions was also considered PD. The percentage of participants who experienced PFS per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.

Time frame:
Up to approximately 66 months
Reported as:
Median · Months
Progression-Free Survival (PFS) Per RECIST 1.1 by Investigator Assessment
MonthsCohort A: Triple Negative Breast Cancer (Lenva + Pembro)Cohort B: Ovarian Cancer (Lenva + Pembro)
Progression-Free Survival (PFS) Per RECIST 1.1 by Investigator Assessment4.2 (1.7 to 6.3)6.1 (4.1 to 9.4)
SecondaryProgression-Free Survival (PFS) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR

PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1 (or RANO for GBM participants), modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥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 ≥5 mm. The appearance of one or more new lesions was also considered PD. For participants with GBM, either radiological progression or clinical deterioration (not attributable to a nontumor-related cause) qualifies as PD. The percentage of participants who experienced PFS per RECIST 1.1 or RANO by BICR is presented. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.

Time frame:
Up to approximately 66 months
Reported as:
Median · Months
Progression-Free Survival (PFS) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
MonthsCohort C: Gastric Cancer (Lenva + Pembro)Cohort D1: Colorectal Cancer (Lenva + Pembro)Cohort D2: Colorectal Cancer (Lenva)Cohort E: Glioblastoma Multiforma (Lenva + Pembro)Cohort F: Biliary Tract Cancer (Lenva + Pembro)Cohort G: Pancreatic Cancer (Lenva + Pembro)
Progression-Free Survival (PFS) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR3.5 (2.3 to 4.1)3.4 (2.1 to 4.1)3.4 (2.1 to 4.8)3.0 (2.8 to 4.1)4.1 (3.6 to 5.9)2.1 (2.1 to 3.1)
SecondaryOverall Survival (OS)

OS was defined as the time from the date of study treatment to the date of death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. The OS for all participants is presented.

Time frame:
Up to approximately 66 months
Reported as:
Median · Months
Overall Survival (OS)
MonthsCohort A: Triple Negative Breast Cancer (Lenva + Pembro)Cohort B: Ovarian Cancer (Lenva + Pembro)Cohort C: Gastric Cancer (Lenva + Pembro)Cohort D1: Colorectal Cancer (Lenva + Pembro)Cohort D2: Colorectal Cancer (Lenva)Cohort E: Glioblastoma Multiforma (Lenva + Pembro)Cohort F: Biliary Tract Cancer (Lenva + Pembro)Cohort G: Pancreatic Cancer (Lenva + Pembro)
Overall Survival (OS)11.4 (4.1 to 21.7)21.3 (11.7 to 32.3)4.7 (3.8 to 6.1)8.7 (7.0 to 10.0)7.9 (5.6 to 14.9)8.6 (7.4 to 10.8)7.9 (5.6 to 9.5)4.3 (3.8 to 5.4)
SecondaryArea Under the Concentration Curve at Steady State (AUCss) of Lenvatinib

Blood samples were collected at pre-specified timepoints to determine the AUCss in participants receiving Lenvatinib (Lenva) co-administered with Pembrolizumab (Pembro). AUCss was defined as a measure of drug exposure that was calculated as the product of plasma drug concentration and time after drug administration at steady state. AUCss determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Noncompartmental analysis was used to calculate AUC0ss for each participant. Mean and standard deviation of AUCss were calculated for each cohort. As specified in the protocol, pharmacokinetic analysis was not planned or conducted in Cohorts D2 and G.

Time frame:
Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose and 2-12 hours post-dose; Cycle 2 Day 1: pre-dose, 0.5-4 hours, and 6-10 hours post-dose (up to approximately 23 days). Each cycle is 21 days.
Reported as:
Mean · ng*hr/mL
Area Under the Concentration Curve at Steady State (AUCss) of Lenvatinib
ng*hr/mLCohort A: Triple Negative Breast Cancer (Lenva + Pembro)Cohort B: Ovarian Cancer (Lenva + Pembro)Cohort C: Gastric Cancer (Lenva + Pembro)Cohort D1: Colorectal Cancer (Lenva + Pembro)Cohort E: Glioblastoma Multiforma (Lenva + Pembro)Cohort F: Biliary Tract Cancer (Lenva + Pembro)
Area Under the Concentration Curve at Steady State (AUCss) of Lenvatinib3253 ± 10293145 ± 9842392 ± 8032994 ± 11432617 ± 8042886 ± 838
PrimaryObjective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator Assessment

ORR was defined as the percentage of participants who had a best overall response of either Complete Response (CR): Disappearance of all target lesions or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions as assessed by RECIST 1.1. The percentage of participants who experienced a CR or PR as assessed by RECIST 1.1 by investigator assessment was presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.

Time frame:
Up to approximately 66 months
Reported as:
Number · Percentage of Participants
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator Assessment
Percentage of ParticipantsCohort A: Triple Negative Breast Cancer (Lenva + Pembro)Cohort B: Ovarian Cancer (Lenva + Pembro)
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator Assessment22.6 (9.6 to 41.1)25.8 (11.9 to 44.6)
PrimaryObjective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for Glioblastoma Multiforma [GBM] Only), by Blinded Independent Central Review (BICR)

ORR was defined as the percentage of participants who had a best overall response of either Complete Response (CR): Disappearance of all target lesions or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions as assessed by RECIST 1.1. For participants with GBM, response was assessed according to RANO criteria whereby ORR was defined as the percentage of participants who had a best overall response of either Complete response (CR): Disappearance of all target lesions or Partial response (PR): sum of products of diameters decreased by ≥50% from baseline value. The percentage of participants who experienced a CR or PR as assessed by RECIST 1.1 or RANO by BICR was presented. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.

Time frame:
Up to approximately 66 months
Reported as:
Number · Percentage of Participants
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for Glioblastoma Multiforma [GBM] Only), by Blinded Independent Central Review (BICR)
Percentage of ParticipantsCohort C: Gastric Cancer (Lenva + Pembro)Cohort D1: Colorectal Cancer (Lenva + Pembro)Cohort D2: Colorectal Cancer (Lenva)Cohort E: Glioblastoma Multiforma (Lenva + Pembro)Cohort F: Biliary Tract Cancer (Lenva + Pembro)Cohort G: Pancreatic Cancer (Lenva + Pembro)
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for Glioblastoma Multiforma [GBM] Only), by Blinded Independent Central Review (BICR)15.2 (8.7 to 23.8)14.3 (8.2 to 22.5)6.7 (0.8 to 22.1)21.8 (14.2 to 31.1)17.6 (10.8 to 26.4)7.8 (3.4 to 14.7)
PrimaryNumber of Participants With One or More Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one or more AE is presented.

Time frame:
Up to approximately 66 months
Reported as:
Count of participants · Participants
Number of Participants With One or More Adverse Events (AEs)
ParticipantsCohort A: Triple Negative Breast Cancer (Lenva + Pembro)Cohort B: Ovarian Cancer (Lenva + Pembro)Cohort C: Gastric Cancer (Lenva + Pembro)Cohort D1: Colorectal Cancer (Lenva + Pembro)Cohort D2: Colorectal Cancer (Lenva)Cohort E: Glioblastoma Multiforma (Lenva + Pembro)Cohort F: Biliary Tract Cancer (Lenva + Pembro)Cohort G: Pancreatic Cancer (Lenva + Pembro)
Number of Participants With One or More Adverse Events (AEs)31319710430101102103
PrimaryNumber of Participants Who Discontinued From Study Treatment Due to an AE

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued from study treatment due to an AE is presented.

Time frame:
Up to approximately 62 months
Reported as:
Count of participants · Participants
Number of Participants Who Discontinued From Study Treatment Due to an AE
ParticipantsCohort A: Triple Negative Breast Cancer (Lenva + Pembro)Cohort B: Ovarian Cancer (Lenva + Pembro)Cohort C: Gastric Cancer (Lenva + Pembro)Cohort D1: Colorectal Cancer (Lenva + Pembro)Cohort D2: Colorectal Cancer (Lenva)Cohort E: Glioblastoma Multiforma (Lenva + Pembro)Cohort F: Biliary Tract Cancer (Lenva + Pembro)Cohort G: Pancreatic Cancer (Lenva + Pembro)
Number of Participants Who Discontinued From Study Treatment Due to an AE51123194112019

Adverse events

Collected over Up to approximately 66 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)27/31 (87.1%)16/31 (51.6%)30/31 (96.8%)
Cohort B: Ovarian Cancer (Lenva + Pembro)28/31 (90.3%)19/31 (61.3%)31/31 (100%)
Cohort C: Gastric Cancer (Lenva + Pembro)97/102 (95.1%)57/99 (57.6%)95/99 (96%)
Cohort D1: Colorectal Cancer (Lenva + Pembro)97/107 (90.7%)55/105 (52.4%)103/105 (98.1%)
Cohort D2: Colorectal Cancer (Lenva)30/32 (93.8%)12/30 (40%)29/30 (96.7%)
Cohort E: Glioblastoma Multiforma (Lenva + Pembro)99/102 (97.1%)30/101 (29.7%)98/101 (97%)
Cohort F: Biliary Tract Cancer (Lenva + Pembro)98/103 (95.1%)62/102 (60.8%)100/102 (98%)
Cohort G: Pancreatic Cancer (Lenva + Pembro)101/103 (98.1%)49/103 (47.6%)101/103 (98.1%)
Most frequent serious events
Showing 10 of 223
Most frequent serious events
EventCohort A: Triple Negative Breast Cancer (Lenva + Pembro)Cohort B: Ovarian Cancer (Lenva + Pembro)Cohort C: Gastric Cancer (Lenva + Pembro)Cohort D1: Colorectal Cancer (Lenva + Pembro)Cohort D2: Colorectal Cancer (Lenva)Cohort E: Glioblastoma Multiforma (Lenva + Pembro)Cohort F: Biliary Tract Cancer (Lenva + Pembro)Cohort G: Pancreatic Cancer (Lenva + Pembro)
Intestinal obstructionGastrointestinal disorders0/313/311/993/1050/300/1010/1020/103
PyrexiaGeneral disorders0/312/311/992/1050/304/1017/1021/103
DiarrhoeaGastrointestinal disorders1/312/313/993/1052/300/1012/1020/103
HyperbilirubinaemiaHepatobiliary disorders0/310/311/990/1052/300/1010/1020/103
VomitingGastrointestinal disorders0/312/312/991/1050/301/1012/1021/103
CholecystitisHepatobiliary disorders0/312/310/990/1051/300/1011/1020/103
PneumoniaInfections and infestations1/312/312/991/1050/301/1012/1021/103
Urinary tract infectionInfections and infestations0/312/310/993/1050/301/1010/1021/103
HyponatraemiaMetabolism and nutrition disorders1/312/310/991/1050/300/1012/1020/103
HeadacheNervous system disorders0/312/310/990/1050/300/1010/1020/103
Most frequent other events
Showing 10 of 107
Most frequent other events
EventCohort A: Triple Negative Breast Cancer (Lenva + Pembro)Cohort B: Ovarian Cancer (Lenva + Pembro)Cohort C: Gastric Cancer (Lenva + Pembro)Cohort D1: Colorectal Cancer (Lenva + Pembro)Cohort D2: Colorectal Cancer (Lenva)Cohort E: Glioblastoma Multiforma (Lenva + Pembro)Cohort F: Biliary Tract Cancer (Lenva + Pembro)Cohort G: Pancreatic Cancer (Lenva + Pembro)
HypertensionVascular disorders16/3121/3137/9959/10517/3051/10158/10255/103
DiarrhoeaGastrointestinal disorders14/3119/3130/9947/10516/3026/10142/10225/103
NauseaGastrointestinal disorders13/3115/3131/9934/1055/3019/10137/10237/103
Decreased appetiteMetabolism and nutrition disorders9/3115/3130/9946/1056/3019/10137/10233/103
HypothyroidismEndocrine disorders14/3114/3125/9946/10512/3028/10134/10228/103
FatigueGeneral disorders13/3114/3121/9941/1059/3020/10140/10231/103
VomitingGastrointestinal disorders10/3113/3115/9926/1058/3013/10120/10219/103
ProteinuriaRenal and urinary disorders6/3113/3112/9939/10511/3012/10123/10222/103
DysphoniaRespiratory, thoracic and mediastinal disorders5/313/3120/9921/10512/3011/10131/10217/103
Blood alkaline phosphatase increasedInvestigations2/316/3114/9913/10511/304/10114/1029/103

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)Cohort B: Ovarian Cancer (Lenva + Pembro)Cohort C: Gastric Cancer (Lenva + Pembro)Cohort D1: Colorectal Cancer (Lenva + Pembro)Cohort D2: Colorectal Cancer (Lenva)Cohort E: Glioblastoma Multiforma (Lenva + Pembro)Cohort F: Biliary Tract Cancer (Lenva + Pembro)Cohort G: Pancreatic Cancer (Lenva + Pembro)Total
<=18 years000000000
Between 18 and 65 years2518687125835256398
>=65 years61334367195147213
Sex: Female, Male
Sex: Female, Male(Participants)Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)Cohort B: Ovarian Cancer (Lenva + Pembro)Cohort C: Gastric Cancer (Lenva + Pembro)Cohort D1: Colorectal Cancer (Lenva + Pembro)Cohort D2: Colorectal Cancer (Lenva)Cohort E: Glioblastoma Multiforma (Lenva + Pembro)Cohort F: Biliary Tract Cancer (Lenva + Pembro)Cohort G: Pancreatic Cancer (Lenva + Pembro)Total
Female3131303214385342271
Male00727518645061340
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)Cohort B: Ovarian Cancer (Lenva + Pembro)Cohort C: Gastric Cancer (Lenva + Pembro)Cohort D1: Colorectal Cancer (Lenva + Pembro)Cohort D2: Colorectal Cancer (Lenva)Cohort E: Glioblastoma Multiforma (Lenva + Pembro)Cohort F: Biliary Tract Cancer (Lenva + Pembro)Cohort G: Pancreatic Cancer (Lenva + Pembro)Total
Hispanic or Latino62171991391691
Not Hispanic or Latino1923647723737686441
Unknown or Not Reported66211101618179
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)Cohort B: Ovarian Cancer (Lenva + Pembro)Cohort C: Gastric Cancer (Lenva + Pembro)Cohort D1: Colorectal Cancer (Lenva + Pembro)Cohort D2: Colorectal Cancer (Lenva)Cohort E: Glioblastoma Multiforma (Lenva + Pembro)Cohort F: Biliary Tract Cancer (Lenva + Pembro)Cohort G: Pancreatic Cancer (Lenva + Pembro)Total
American Indian or Alaska Native000000000
Asian54111721718882
Native Hawaiian or Other Pacific Islander000001001
Black or African American0024201211
White2223707125727190444
More than one race0024310313
Unknown or Not Reported44171101113060
08

Study locations

88 sites
  • City of Hope ( Site 0002)
    Duarte, California 91010, United States
  • Cedars Sinai Medical Center ( Site 0003)
    Los Angeles, California 90048, United States
  • University of California Davis Comprehensive Cancer Center ( Site 0005)
    Sacramento, California 95817, United States
  • University of Colorado, Anschutz Cancer Pavilion ( Site 0007)
    Aurora, Colorado 80045, United States
  • University of Florida-Health Cancer Center-Orlando ( Site 0015)
    Orlando, Florida 32806, United States
  • Rutgers Cancer Institute of New Jersey ( Site 0009)
    New Brunswick, New Jersey 08901, United States
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0023)
    New York, New York 10016, United States
  • Sanford Fargo Medical Center ( Site 0059)
    Fargo, North Dakota 58102, United States
  • Lehigh Valley Hospital- Cedar Crest ( Site 0047)
    Allentown, Pennsylvania 18103, United States
  • Sanford Cancer Center ( Site 0058)
    Sioux Falls, South Dakota 57104, United States
  • West Cancer Center - East Campus ( Site 0018)
    Germantown, Tennessee 38138, United States
  • Mary Crowley Cancer Research Centers - Medical City Hospital ( Site 0049)
    Dallas, Texas 75230, United States
  • Swedish Medical Center ( Site 0021)
    Seattle, Washington 98104, United States
  • University of Wisconsin Carbone Cancer Center ( Site 0017)
    Madison, Wisconsin 53792-0001, United States
  • Fundacion Favaloro para la Docencia e Investigacion Medica ( Site 2106)
    Ciudad Autonoma de Buenos Aires, Buenos Aires C1078AAI, Argentina
  • Hospital Aleman ( Site 2100)
    Buenos Aires, Buenos Aires F.D. 1118, Argentina
  • Hospital Britanico de Buenos Aires ( Site 2109)
    Ciudad de Buenos Aires, Buenos Aires F.D. C1280AEB, Argentina
  • Instituto de Oncologia de Rosario ( Site 2105)
    Rosario, Santa Fe Province S2000KZE, Argentina
  • CEMIC ( Site 2104)
    Buenos Aires, C1431FWO, Argentina
  • IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2101)
    Caba, C1012AAR, Argentina
  • Royal Brisbane and Women s Hospital ( Site 0901)
    Herston, Queensland 4029, Australia
  • Alfred Health ( Site 0902)
    Melbourne, Victoria 3004, Australia
  • Sir Charles Gairdner Hospital ( Site 0903)
    Nedlands, Western Australia 6009, Australia
  • BC Cancer - Abbotsford ( Site 0200)
    Abbotsford British Columbia, British Columbia V2S 0C2, Canada
  • CancerCare Manitoba ( Site 0201)
    Winnipeg, Manitoba R3E 0V9, Canada
  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0208)
    Hamilton, Ontario L8V 4X2, Canada
  • Sunnybrook Research Institute ( Site 0207)
    Toronto, Ontario M4N 3M5, Canada
  • Princess Margaret Cancer Centre ( Site 0202)
    Toronto, Ontario M5G 2M9, Canada
  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0210)
    Montreal, Quebec H2X 3E4, Canada
  • CHU de Quebec Universite de Laval ( Site 0206)
    Québec, Quebec G1R 2J6, Canada
  • Centro Investigación del Cáncer James Lind ( Site 1203)
    Temuco, Araucania 4780000, Chile
  • Fundacion Arturo Lopez Perez ( Site 1201)
    Santiago, Region M. de Santiago 7500921, Chile
  • Pontificia Universidad Catolica de Chile ( Site 1202)
    Santiago, Region M. de Santiago 8330024, Chile
  • Hospital Clinico Universidad de Chile ( Site 1200)
    Santiago, Region M. de Santiago 8380456, Chile
  • Fundacion Colombiana de Cancerologia Clinica Vida ( Site 1105)
    Medellín, Antioquia 050030, Colombia
  • Instituto Nacional de Cancerologia E.S.E ( Site 1102)
    Bogotá, Bogota D.C. 110321, Colombia
  • Oncologos del Occidente S.A. ( Site 1106)
    Pereira, Risaralda Department 660001, Colombia
  • Fundacion Valle del Lili ( Site 1101)
    Cali, Valle del Cauca Department 760032, Colombia
  • Centre Antoine Lacassagne ( Site 0404)
    Nice, Alpes-Maritimes 06189, France
  • Centre Leon Berard ( Site 0405)
    Lyon, Auvergne 69373, France
  • Institut Claudius Regaud IUCT Oncopole ( Site 0403)
    Toulouse, Haute-Garonne 31059, France
  • Centre Oscar Lambret ( Site 0401)
    Lille, Nord 59000, France
  • Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0402)
    Saint-Herblain, Val-de-Marne 44805, France
  • Institut Gustave Roussy ( Site 0400)
    Villejuif, Val-de-Marne 94800, France
  • Robert Bosch GmbH ( Site 0307)
    Stuttgart, Baden-Wurttemberg 70376, Germany
  • Universitaetsklinikum Regensburg ( Site 0304)
    Regensburg, Bavaria 93053, Germany
  • Universitaetsklinikum Frankfurt ( Site 0306)
    Frankfurt am Main, Hesse 60528, Germany
  • HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0301)
    Wiesbaden, Hesse 65199, Germany
  • SRH Wald-Klinikum Gera GmbH ( Site 0309)
    Gera, Thuringia 07548, Germany
  • Universitaetsklinikum Jena ( Site 0302)
    Jena, Thuringia 07740, Germany
  • Soroka Medical Center ( Site 0601)
    Beersheba, 8457108, Israel
  • Rambam Medical Center ( Site 0602)
    Haifa, 3109601, Israel
  • Hadassah Ein Kerem Medical Center ( Site 0604)
    Jerusalem, 9112001, Israel
  • Chaim Sheba Medical Center ( Site 0600)
    Ramat Gan, 5262000, Israel
  • Sourasky Medical Center ( Site 0603)
    Tel Aviv, 6423906, Israel
  • Istituto Clinico Humanitas Research Hospital ( Site 1402)
    Rozzano, Milano, Italy
  • Policlinico Le Scotte - A.O. Senese ( Site 1401)
    Siena, Tuscany 53100, Italy
  • Istituto Nazionale Tumori Fondazione Pascale ( Site 1400)
    Naples, 80131, Italy
  • Fondazione Policlinico Universitario A. Gemelli ( Site 1403)
    Roma, 00168, Italy
  • Arkhangelsk Clinical Oncological Dispensary ( Site 1600)
    Arkhangelsk, Arkhangelskaya oblast 163045, Russia
  • Russian Oncological Research Center n.a. N.N. Blokhin ( Site 1604)
    Moscow, Moscow 115478, Russia
  • Leningrad Regional Oncology Center ( Site 1609)
    Saint Petersburg, Sankt-Peterburg 188663, Russia
  • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1610)
    Saint Petersburg, Sankt-Peterburg 197758, Russia
  • City Clinical Oncology Center ( Site 1608)
    Saint Petersburg, Sankt-Peterburg 198255, Russia
  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1603)
    Kazan', Tatarstan, Respublika 420029, Russia
  • Asan Medical Center ( Site 1002)
    Songpagu, Seoul 05505, South Korea
  • Seoul National University Hospital ( Site 1000)
    Seoul, 03080, South Korea
  • Severance Hospital Yonsei University Health System ( Site 1001)
    Seoul, 03722, South Korea
  • Hospital Clinic i Provincial ( Site 0703)
    Barcelona, 08036, Spain
  • Hospital Universitario Gregorio Maranon ( Site 0701)
    Madrid, 28009, Spain
  • Clinica Universitaria de Navarra ( Site 0704)
    Madrid, 28027, Spain
  • Hospital Ramon y Cajal ( Site 0702)
    Madrid, 28034, Spain
  • Inselspital Universitaetsspital Bern ( Site 1705)
    Bern, Canton of Bern 3010, Switzerland
  • Kantonsspital St. Gallen ( Site 1702)
    Sankt Gallen, Canton of St. Gallen 9007, Switzerland
  • Ospedale Regionale di Bellinzona e Valli ( Site 1703)
    Bellinzona, Canton Ticino 6500, Switzerland
  • Kantonsspital Graubuenden ( Site 1704)
    Chur, Kanton Graubünden 7000, Switzerland
  • Hopitaux Universitaires de Geneve HUG ( Site 1701)
    Geneva, 1211, Switzerland
  • Universitaetsspital Zurich ( Site 1700)
    Zurich, 8091, Switzerland
  • National Cheng Kung University Hospital ( Site 3003)
    Tainan, 704, Taiwan
  • National Taiwan University Hospital ( Site 3000)
    Taipei, 10002, Taiwan
  • Chulalongkorn University ( Site 5001)
    Bangkok, Bangkok 10330, Thailand
  • Ramathibodi Hospital. ( Site 5002)
    Bangkok, Bangkok 10400, Thailand
  • Siriraj Hospital ( Site 5003)
    Bangkok, Bangkok 10700, Thailand
  • Cambridge University Hospitals NHS Trust ( Site 0803)
    Cambridge, Cambridgeshire CB2 0QQ, United Kingdom
  • Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 0804)
    Leicester, Leicestershire LE1 5WW, United Kingdom
  • Guy's Hospital ( Site 0806)
    London, London, City of SE1 9RT, United Kingdom
  • Royal Marsden Hospital (Sutton) ( Site 0800)
    London, Surrey SM3 5PT, United Kingdom
  • Christie NHS Foundation Trust ( Site 0805)
    Manchester, M20 4BX, United Kingdom
09

References and documents

Publications

  • Gonzalez-Martin A, Chung HC, Saada-Bouzid E, Yanez E, Senellart H, Cassier PA, Basu B, Corr BR, Girda E, Dutcus C, Okpara CE, Ghori R, Jin F, Groisberg R, Lwin Z. Lenvatinib plus pembrolizumab for patients with previously treated advanced ovarian cancer: Results from the phase 2 multicohort LEAP-005 study. Gynecol Oncol. 2024 Jul;186:182-190. doi: 10.1016/j.ygyno.2024.04.011. Epub 2024 May 7. PubMed 38718741 ↗
  • Chung HC, Saada-Bouzid E, Longo F, Yanez E, Im SA, Castanon E, Desautels DN, Graham DM, Garcia-Corbacho J, Lopez J, Dutcus C, Okpara CE, Ghori R, Jin F, Groisberg R, Korakis I. Lenvatinib plus pembrolizumab for patients with previously treated, advanced, triple-negative breast cancer: Results from the triple-negative breast cancer cohort of the phase 2 LEAP-005 Study. Cancer. 2024 Oct 1;130(19):3278-3288. doi: 10.1002/cncr.35387. Epub 2024 Jun 21. PubMed 39031824 ↗
  • Ponz-Sarvise M, Rha SY, Gomez-Roca CA, Ortega Moran L, Gill S, Tortora G, Geva R, Saada-Bouzid E, Santoro A, Kim TW, Heudobler D, Dutcus CE, Okpara CE, Ghori R, Zhang Y, Vajdi A, Dettman EJ, Jin F, Groisberg R, Shapira-Frommer R. Lenvatinib plus Pembrolizumab for Patients with Previously Treated Advanced Gastric, Biliary Tract, or Pancreatic Cancer: Results from the Phase II LEAP-005 Study. Cancer Res Commun. 2026 Mar 1;6(3):673-686. doi: 10.1158/2767-9764.CRC-26-0018. PubMed 41747221 ↗
  • Victoria Ruiz I, Uboha NV, Jamal R, Mejia FC, Ahumada M, Im SA, Gomez-Roca C, Shapira-Frommer R, Perets R, Yanez E, Dutcus C, Okpara CE, Ghori R, Jin F, Groisberg R, Castanon E. Lenvatinib Plus Pembrolizumab for Patients With Previously Treated Advanced Colorectal Cancer: Results From the Phase II LEAP-005 Study. Clin Colorectal Cancer. 2026 Jun;25(2):225-238.e2. doi: 10.1016/j.clcc.2026.01.003. Epub 2026 Jan 22. PubMed 41763955 ↗
  • Rha SY, Castanon E, Gill S, Senellart H, Lopez J, Marquez-Rodas I, Victoria I, Kim TM, Lwin Z, Burger MC, Simonelli M, Cassier PA, Hendifar AE, Ascierto PA, Dutcus C, Okpara CE, Ghori R, Jin F, Groisberg R, Villanueva L. Lenvatinib plus pembrolizumab for patients with previously treated select solid tumors: Results from the phase 2 LEAP-005 study recurrent glioblastoma cohort. Cancer. 2025 Aug 15;131(16):e70015. doi: 10.1002/cncr.70015. PubMed 40808295 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 18, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03797326
Lead sponsor
Merck Sharp & Dohme LLC
Collaborators
Eisai Inc.
Responsible party
Sponsor
First posted
Jan 9, 2019
Start date
Feb 12, 2019
Primary completion
Oct 28, 2024
Completion
Oct 28, 2024
Results posted
Nov 17, 2025
Last update
May 4, 2026

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions 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.

Other studies in this condition

Triple Negative Breast Neoplasms→

Other studies from this sponsor

Merck Sharp & Dohme LLC

Start the discussion