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Clinical Trials List

Protocol NumberMK3475-679/ECHO-302
NCT Number(ClinicalTrials.gov Identfier)NCT03260894

2017-11-01 - 2022-06-27

Phase III

Terminated6

ICD-10C65

Malignant neoplasm of renal pelvis

ICD-10C64

Malignant neoplasm of kidney, except renal pelvis

A Randomized, Open-Label, Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care (Sunitinib or Pazopanib) as First-Line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-679/ECHO-302)

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

    Merck Sharp & Dohme Corp.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Tzu-Ping Lin Division of Urology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Wen-Pin Su Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator Yu-Li Su Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chao-Hsiang Chang Division of Urology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator See-Tong Pang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Taiwan National PI

馮思中

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Condition/Disease

Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC)

Objectives

-To compare the progression-free survival (PFS) of pembrolizumab plus epacadostat versus standard of care (SOC) (sunitinib or pazopanib) -To compare the overall survival (OS) of pembrolizumab plus epacadostat versus SOC

Test Drug

Pembrolizumab; Epacadostat

Active Ingredient

Epacadostat
Pembrolizumab

Dosage Form

injection
tablet

Dosage

100 mg/4 mL/vial
100 mg/tablet、25 mg/tablet

Endpoints

Primary Outcome Measures :
Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC) [ Time Frame: Minimum up to 6 months ]
ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.


Secondary Outcome Measures :
Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months. ]
AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Discontinuing Study Drug Due to AEs [ Time Frame: Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months. ]
AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Inclution Criteria

Inclusion Criteria
Participants are eligible to be included in the study only if all of the following
criteria apply:
1. Has histologic confirmation of locally advanced or metastatic RCC (Stage
IV per American Joint Committee on Cancer) with a clear cell component
with or without sarcomatoid features.
2. Must not have received any prior systemic therapy for their mRCC.
3. Have measurable disease per RECIST 1.1 as determined by the site. Tumor
lesions situated in a previously irradiated area are considered measurable if
progression has been demonstrated in such lesions.
4. Have provided archival tumor tissue sample or newly obtained core or
excisional biopsy of a tumor lesion not previously irradiated. The tumor
tissue must have been obtained prior to randomization and after the latest
systemic treatment for RCC.
5. Have a Karnofsky performance status of ≥ 70 within 14 days prior to
randomization. (See Appendix 10).
6. Male/female participants who are at least 18 years of age on the day of
signing the informed consent.
7. A male participant must agree to use contraception, as detailed in Appendix
2 of this protocol, during the treatment period and for at least 120 days after
the last dose of pembrolizumab and epacadostat and up to 180 days after last
dose of SOC agents and refrain from donating sperm during this period.
Note: Abstinence is acceptable if this is the usual lifestyle and preferred
contraception for the participant.
8. A female participant is eligible to participate if she is not pregnant (see
Appendix 2), not breastfeeding, and at least one of the following conditions
applies:
a) Not a woman of childbearing potential (WOCBP), as defined in
Appendix 2
OR
b) A WOCBP who agrees to follow the contraceptive guidance in Appendix
2 during the treatment period and for at least 120 days after the last dose of
pembrolizumab and epacadostat and up to 180 days after last dose of SOC
agents. Note: Abstinence is acceptable if this is the usual lifestyle and
preferred contraception for the participant.
9. The participant (or legally acceptable representative if applicable) provides
written informed consent for the trial.
10. Have adequate organ function as defined in the following table. Specimens
must be collected within 14 days prior to randomization.

Exclusion Criteria

Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
1. Has a history of severe hypersensitivity reaction (eg, generalized
rash/erythema, hypotension, bronchospasm, angioedema or anaphylaxis) to
study treatments or their excipients.
2. Has a diagnosis of immunodeficiency or is receiving chronic systemic
steroid therapy (doses exceeding 10 mg daily of prednisone equivalent) or
any other form of immunosuppressive therapy within 7 days prior the first
dose of study treatment. Corticosteroid use as premedication for IV contrast
prophylaxis is permitted.
3. Has an active autoimmune disease that has required systemic treatment in
past 2 years (ie, with use of disease modifying agents, corticosteroids or
immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency, etc.) is not considered systemic treatment.
4. Has a known additional malignancy that has progressed or has required
active systemic treatment in the last 3 years. Note: participants with
curatively treated basal cell carcinoma of the skin, superficial bladder
cancer, squamous cell carcinoma of the skin, curatively resected in situ
cervical cancer and curatively resected in situ breast cancer are not
excluded.
5. Has known active central nervous system metastases and/or carcinomatous
meningitis. Participants with previously treated brain metastases may
participate provided they are radiologically stable (without evidence of
progression by imaging for at least 4 weeks prior to the first dose of study
treatment), clinically stable, and have not required steroids for at least 14
days before first dose of study treatment.
6. Has a history of (non-infectious) pneumonitis that required steroids or has
current pneumonitis.
7. Has an active infection requiring systemic therapy.
8. Has a known history of human immunodeficiency virus (HIV) infection. No
HIV testing is required unless mandated by local health authority.
9. Has a known history of or is positive for active Hepatitis B (HBsAg
reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be
performed to determine eligibility.
a) HBV DNA must be undetectable and HBsAg negative at Screening
visit.
b) Hepatitis C Ab testing is allowed for screening purposes in countries
where HCV RNA is not part of SOC. In these cases, HCV antibody
positive participants will be excluded.
c) Participants who have had definitive treatment for HCV are permitted
if HCV RNA is undetectable at Screening visit.
10. Has any history of serotonin syndrome after receiving serotonergic drugs.
11. Has a history of a gastrointestinal condition or procedure that in the opinion
of the Investigator may affect oral drug absorption.
12. Has a history of any of the following cardiovascular conditions within 12
months prior to randomization: myocardial infarction, unstable angina
pectoris, cardiac angioplasty or stenting, coronary/peripheral artery bypass
graft, Class III or IV congestive heart failure per New York Heart
Association (NYHA), cerebrovascular accident or transient ischemic attack, or NYHA Class III or IV congestive heart failure (CHF) (see Appendix 11).
Medically controlled arrhythmia stable on medication is permitted.
13. Has a history of deep vein thrombosis or pulmonary embolism within 6
months of screening.
14. Poorly controlled hypertension (defined as systolic BP ≥ 150 mm Hg or
diastolic BP ≥ 90 mm Hg). Initiation or adjustment of antihypertensive
medication(s) is permitted prior to randomization.
15. Has a history or presence of an abnormal electrocardiogram (ECG) that, in
the Investigator's opinion, is clinically meaningful. Screening QTc interval >
480 msec is excluded (corrected by Fridericia or Bazett formula). In the
event that a single QTc is > 480 msec, the participant may enroll if the
average QTc for 3 ECGs is < 480 msec.
16. WOCBP who has a positive urine pregnancy test within 72 hours before the
first dose of study treatment. If the urine test is positive or cannot be
confirmed as negative, a serum pregnancy test will be required.
Note: In the event that 72 hours have elapsed between the screening
pregnancy test and the first dose of study treatment, another pregnancy test
(urine or serum) must be performed and must be negative in order for
participant to start receiving study treatment.
17. 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 pembrolizumab and epacadostat and
up to 180 days after last dose of chemotherapeutic agents.
18. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2
agent, with epacadostat or any anti-IDO1 agent, or with an agent directed to
another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40,
CD137).
19. Has received prior therapy with vascular endothelial growth factor
(VEGF)/VEGF receptors (VEGFR) or mechanistic target of rapamycin
(mTOR) targeting agents in locally advanced/metastatic setting.
Note: Prior neoadjuvant/adjuvant therapy for RCC with those agents is
acceptable if completed > 12 months prior to randomization.
20. Has received prior systemic anti-cancer therapy including investigational
agents within 4 weeks prior to randomization.
Note: Participants must have recovered from all AEs due to previous
therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy
may be eligible.
21. If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting
study treatment.
22. Has received live vaccine within 30 days before the first dose of study
treatment. Examples of live vaccines include, but are not limited to, the
following: measles, mumps, rubella, chicken pox, yellow fever, rabies,
Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza
vaccines for injection are generally killed virus vaccines and are allowed;
however, intranasal influenza vaccines are live attenuated vaccines and are
not allowed.
23. Has received therapy with a monoamine oxidase inhibitor (MAOI),
melatonin supplement, or UGT1A9 inhibitor within 21 days prior to
randomization, or anticipates requiring one of these prohibited medications
during the treatment phase. Examples of medications in these classes are
found in Section 7.7.2.
Note: Propofol, if administered for an on-study biopsy procedure, may be
permitted per Section 7.7.2.
24. Has current use (within 7 days of randomization) or anticipated need for
treatment with drugs or foods that are known strong cytochrome P450
(CYP3A4/5) inhibitors including, but not limited to, atazanavir,
clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone,
nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin,
voriconazole, and grapefruit or grapefruit juice. Note: The topical use of
these medications, such as 2% ketoconazole cream, is allowed.
25. Current use of any prohibited medication as described in Section 7.7.2 –
Prohibited Medications or Therapies.
26. 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.
Note: Participants who have entered the follow-up phase of an
investigational study may participate as long as it has been 4 weeks after the
last dose of the previous investigational agent.
27. Has known psychiatric or substance abuse disorders that would interfere
with cooperating with the requirements of the study.
28. Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the study, interfere with the
participant's participation for the full duration of the study, or is not in the
best interest of the participant to participate, in the opinion of the treating
investigator.

The Estimated Number of Participants

  • Taiwan

    3 participants

  • Global

    130 participants

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