Clinical Trials List
Protocol NumberMK3475-672
NCT Number(ClinicalTrials.gov Identfier)NCT03361865
2018-01-15 - 2020-12-25
Phase III
Terminated5
ICD-10C66.2
Malignant neoplasm of left ureter
ICD-9188.9
Malignant neoplasm of bladder, part unspecified
A Phase 3 Randomized, Double-Blind Trial of Pembrolizumab (MK-3475) in Combination With Epacadostat (INCB024360) or Placebo in Participants With Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)
-
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
Co-Principal Investigator
- Yen-Hwa Chang Division of Urology
- Chueh-Chuan Yen Division of Hematology & Oncology
- Yi-Hsiu Huang Division of Urology
- 沈書慧 Division of Radiology
- Hsiao-Jen Chung Division of Urology
- Mu-Hsin Chang Division of Hematology & Oncology
- Tzeon-jye Chiou Division of General Internal Medicine
- 潘競成 Division of Others
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Che-Hung Lin Division of Hematology & Oncology
- Chao-Hsiang Chang Division of Urology
- Chi-Rei Yang Division of Urology
- Wei-Ching Lin Division of Radiology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Shang-Yin Wu Division of Hematology & Oncology
- Wu-Chou Su Division of Hematology & Oncology
- Ya-Ting Hsu Division of Hematology & Oncology
- Sin-Syue Li Division of Hematology & Oncology
- Jui-Hung Tsai Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
- 劉建廷 Division of Hematology & Oncology
- Shau-Hsuan Li Division of Hematology & Oncology
- 吳佳哲 Division of Hematology & Oncology
- 陳彥仰 Division of Hematology & Oncology
- 陳彥豪 Division of Hematology & Oncology
- Tai-Jan Chiu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Yu-Chieh Tsai Division of Hematology & Oncology
- CHUNG-HSIN CHEN Division of Urology
- Yeong-Shiau Pu Division of Urology
- JHE-CYUAN GUO Division of Hematology & Oncology
- Ying-Chun Shen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Urothelial Cancer
Objectives
Primary Objective:
-To demonstrate the superiority of pembrolizumab and epacadostat versus pembrolizumab and placebo in progression-free
survival (PFS).
-To demonstrate the superiority of pembrolizumab and epacadostat versus pembrolizumab and placebo in overall survival (OS).
Secondary Objective:
-To evaluate the safety and tolerability of participants treated with pembrolizumab plus epacadostat to those treated with pembrolizumab plus placebo.
-To demonstrate the superiority of pembrolizumab and epacadostat versus pembrolizumab and placebo in objective response
rate (ORR).
-To evaluate and compare mean change from baseline and time to true deterioration (TTD) in global health status/quality of life (QoL), in both treatment groups.
Test Drug
Keytruda / Epacadostat
Active Ingredient
Epacadostat
Pembrolizumab
Pembrolizumab
Dosage Form
Injection
tablet
tablet
Dosage
100
100
100
Endpoints
Primary Outcome Measures :
Objective Response Rate (ORR) With Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo [ Time Frame: Week 9 ]
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.
Responses are based on Investigator assessments per RECIST 1.1 without confirmation using all scans up to the cutoff date.
Secondary Outcome Measures :
Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to approximately 9 months at data cut-off 15-AUG-2018 ]
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 Pembrolizumab + Placebo as Measured by Number of Participants Discontinuing Study Treatment Due to AE [ Time Frame: Up to approximately 9 months at data cut-off 15-AUG-2018 ]
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.
Objective Response Rate (ORR) With Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo [ Time Frame: Week 9 ]
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.
Responses are based on Investigator assessments per RECIST 1.1 without confirmation using all scans up to the cutoff date.
Secondary Outcome Measures :
Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to approximately 9 months at data cut-off 15-AUG-2018 ]
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 Pembrolizumab + Placebo as Measured by Number of Participants Discontinuing Study Treatment Due to AE [ Time Frame: Up to approximately 9 months at data cut-off 15-AUG-2018 ]
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:
Type of Participant and Disease Characteristics
1. Have histologically or cytologically-confirmed diagnosis of
advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal
pelvis, ureter, bladder, or urethra. Both transitional cell and mixed
transitional/non-transitional (predominantly transitional) cell histologies are
allowed. Participants with non-urothelial cancer of the urinary tract are not
allowed.
2. Have measureable disease based on RECIST 1.1 as assessed by the local site
investigator/radiology. Tumor lesions situated in a previously irradiated area are
considered measureable if progression has been demonstrated in such lesions.
3. Be considered ineligible to receive cisplatin-based combination therapy, based on
having at least one of the following criteria:
a. ECOG PS of 2 within 14 days prior to randomization (the proportion of
participants with an ECOG PS of 2 will be limited to approximately 50%
of the total population)
b. CrCl (calculated or measured) <60 mL/min but ≥30 mL/min
Note: Participants with a CrCl (calculated or measured) <30 mL/min or
on dialysis are excluded from the study.
c. CTCAE v.4.0, Grade ≥2 audiometric hearing loss (25 dB in two
consecutive wave ranges)
d. CTCAE v.4.0, Grade ≥2 peripheral neuropathy
e. New York Heart Association (NYHA) Class III heart failure (Protocol
Appendix 6)
4. Have provided tissue for PD-L1 analysis from an archival tissue sample or newly
obtained core or excisional biopsy of a tumor lesion not previously irradiated. A
newly obtained biopsy is strongly preferred but not required if archival tissue is
adequate for analysis. If submitting unstained cut slides, freshly cut slides should
be submitted to the central laboratory within 14 days from when the slides are
cut. Refer to Section 9.8.1 in the protocol for an explanation. PD-L1 status (CPS
≥10 or CPS <10) must be determined by the central laboratory prior to
randomization. Participants will be excluded if PD-L1 status cannot be
determined.
5. Have received no prior systemic chemotherapy for advanced/unresectable
(inoperable) or metastatic urothelial cancer
a. Adjuvant platinum based chemotherapy, following radical cystectomy, with
recurrence >12 months from completion of therapy is permitted.
OR
b. Neoadjuvant platinum based chemotherapy, with recurrence >12 months since
completion of therapy is permitted.
Note: Low-dose chemotherapy (eg, low dose cisplatin, cisplatin + fluorouracil
(5-FU), mitomycin + 5-FU, or cisplatin + paclitaxel) given concurrent with
radiation to the primary tumor site is not considered as systemic therapy. In the
clinical setting, chemotherapy is given with the sole purpose of sensitizing the
tumor to local radiation. It is not administered at doses with any systemic
efficacy. Surgery is not considered first- line therapy following diagnosis of
advanced/metastatic disease.
Demographics
6. Be ≥ 18 years of age on day of signing informed consent.
7. Have a PS of 0, 1 or 2 within 14 days prior to randomization on the ECOG
Performance Scale.
Male participants:
8. A male participant must agree to use a contraception as detailed in Appendix 5
of this protocol during the treatment period and for at least 120 days after the last
dose of study treatment and refrain from donating sperm during this period.
Female participants:
9. A female participant is eligible to participate if she is not pregnant (see
Appendix 5), not breastfeeding, and at least one of the following conditions
applies:
a.) Not a woman of childbearing potential (WOCBP) as defined in Protocol
Appendix 5 OR
b.) A WOCBP who agrees to follow the contraceptive guidance in Appendix 5
during the treatment period and for at least 120 days [corresponding to time
needed to eliminate any study treatments (MK-3475 and epacadostat) after the
last dose of study treatment].
Informed Consent
10. The participant (or legally acceptable representative if applicable) provides
written informed consent for the trial.
Laboratory Values
11. Demonstrate adequate organ function as defined in Table 1. All screening labs
must be collected within 14 days prior to randomization.
Participants are eligible to be included in the study only if all of the following criteria
apply:
Type of Participant and Disease Characteristics
1. Have histologically or cytologically-confirmed diagnosis of
advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal
pelvis, ureter, bladder, or urethra. Both transitional cell and mixed
transitional/non-transitional (predominantly transitional) cell histologies are
allowed. Participants with non-urothelial cancer of the urinary tract are not
allowed.
2. Have measureable disease based on RECIST 1.1 as assessed by the local site
investigator/radiology. Tumor lesions situated in a previously irradiated area are
considered measureable if progression has been demonstrated in such lesions.
3. Be considered ineligible to receive cisplatin-based combination therapy, based on
having at least one of the following criteria:
a. ECOG PS of 2 within 14 days prior to randomization (the proportion of
participants with an ECOG PS of 2 will be limited to approximately 50%
of the total population)
b. CrCl (calculated or measured) <60 mL/min but ≥30 mL/min
Note: Participants with a CrCl (calculated or measured) <30 mL/min or
on dialysis are excluded from the study.
c. CTCAE v.4.0, Grade ≥2 audiometric hearing loss (25 dB in two
consecutive wave ranges)
d. CTCAE v.4.0, Grade ≥2 peripheral neuropathy
e. New York Heart Association (NYHA) Class III heart failure (Protocol
Appendix 6)
4. Have provided tissue for PD-L1 analysis from an archival tissue sample or newly
obtained core or excisional biopsy of a tumor lesion not previously irradiated. A
newly obtained biopsy is strongly preferred but not required if archival tissue is
adequate for analysis. If submitting unstained cut slides, freshly cut slides should
be submitted to the central laboratory within 14 days from when the slides are
cut. Refer to Section 9.8.1 in the protocol for an explanation. PD-L1 status (CPS
≥10 or CPS <10) must be determined by the central laboratory prior to
randomization. Participants will be excluded if PD-L1 status cannot be
determined.
5. Have received no prior systemic chemotherapy for advanced/unresectable
(inoperable) or metastatic urothelial cancer
a. Adjuvant platinum based chemotherapy, following radical cystectomy, with
recurrence >12 months from completion of therapy is permitted.
OR
b. Neoadjuvant platinum based chemotherapy, with recurrence >12 months since
completion of therapy is permitted.
Note: Low-dose chemotherapy (eg, low dose cisplatin, cisplatin + fluorouracil
(5-FU), mitomycin + 5-FU, or cisplatin + paclitaxel) given concurrent with
radiation to the primary tumor site is not considered as systemic therapy. In the
clinical setting, chemotherapy is given with the sole purpose of sensitizing the
tumor to local radiation. It is not administered at doses with any systemic
efficacy. Surgery is not considered first- line therapy following diagnosis of
advanced/metastatic disease.
Demographics
6. Be ≥ 18 years of age on day of signing informed consent.
7. Have a PS of 0, 1 or 2 within 14 days prior to randomization on the ECOG
Performance Scale.
Male participants:
8. A male participant must agree to use a contraception as detailed in Appendix 5
of this protocol during the treatment period and for at least 120 days after the last
dose of study treatment and refrain from donating sperm during this period.
Female participants:
9. A female participant is eligible to participate if she is not pregnant (see
Appendix 5), not breastfeeding, and at least one of the following conditions
applies:
a.) Not a woman of childbearing potential (WOCBP) as defined in Protocol
Appendix 5 OR
b.) A WOCBP who agrees to follow the contraceptive guidance in Appendix 5
during the treatment period and for at least 120 days [corresponding to time
needed to eliminate any study treatments (MK-3475 and epacadostat) after the
last dose of study treatment].
Informed Consent
10. The participant (or legally acceptable representative if applicable) provides
written informed consent for the trial.
Laboratory Values
11. Demonstrate adequate organ function as defined in Table 1. All screening labs
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:
Medical Conditions
1. Has disease that is suitable for local therapy administered with curative intent.
2. Has a known additional malignancy that is progressing or has required active
treatment within the past 3 years.
Note: Participants with basal cell carcinoma of the skin, squamous cell
carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer
in situ) that have undergone potentially curative therapy are not excluded.
Participants with low-risk early stage prostate cancer defined as follows are not
excluded; Stage T1c or T2a with a Gleason score ≤ 6 and prostatic-specific
antigen (PSA) < 10 ng/mL either treated with definitive intent or untreated in
active surveillance that has been stable for the past year prior to study allocation.
3. Has known active central nervous system (CNS) metastases and/or
carcinomatous meningitis. Participants with previously treated brain metastases
may participate provided they are radiologically stable, ie, without evidence of
progression for at least 4 weeks by repeat imaging, (note that repeat imaging should be performed during the study screening), clinically stable and without
requirement of steroid treatment for at least 14 days prior to first dose of study
treatment.
4. 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) is not considered a form of systemic treatment and is allowed.
5. 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.
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 known history of or is positive for active Hepatitis B (Hepatitis B surface
antigen [HBsAg] reactive) or has active Hepatitis C (HCV RNA). Note: Testing
must be performed to determine eligibility.
HBV DNA must be undetectable and HBsAg negative at screening visit.
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.
Participants who have had definitive treatment for HCV are permitted if
HCV RNA undetectable at Screening Visit.
10. Has a history of a gastrointestinal condition or procedure that in the opinion of
the Investigator may affect oral drug absorption.
11. Has a history or presence of an abnormal electrocardiogram (ECG) that, in the
investigator's opinion, is clinically meaningful. Screening corrected QT interval
(QTc) interval >480 milliseconds is excluded (corrected by Fridericia or Bazett
formula). In the event that a single QTc is >480 milliseconds, the participant
may enroll if the average QTc for the 3 ECGs is <480 milliseconds.
12. Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the trial, interfere with the
participant's participation for the full duration of the trial, or is not in the best
interest of the participant to participate, in the opinion of the treating
investigator.
13. Has known psychiatric or substance abuse disorders that would interfere with
cooperating with the requirements of the study.
14. A WOCBP who has a positive urine pregnancy test within 72 hours before
randomization (see Appendix 5). If the urine test cannot be confirmed as
negative, a serum pregnancy test is required. In such cases, the participant
must be excluded from participation if the serum pregnancy result is positive.
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.
15. Is pregnant or breastfeeding or expecting to conceive or father children within
the projected duration of the trial, starting with the screening visit through 120
days after the last dose of pembrolizumab and epacadostat/matching placebo.
Prior/Concomitant Therapy
16. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti PD-L2 agent,
IDO1 inhibitor, or with an agent directed to another stimulatory or co-inhibitory
T-cell receptor (eg, CTLA-4, OX 40, CD137), or any other antibody or drug
targeting T-cell co-stimulatory pathways in the adjuvant or advanced/metastatic
setting.
17. 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.
Note: If participant received major surgery, they must have recovered adequately
from the toxicity and/or complications from the intervention prior to starting
study treatment.
18. Has received prior radiotherapy within 2 weeks of start of trial treatment.
Participants must have recovered from all radiation-related toxicities, and not
require corticosteroids. A 1-week washout is permitted for palliative radiation
(≤2 weeks of radiotherapy) to non- CNS disease.
19. Has received a live vaccine within 30 days prior to the first dose of trial drug.
Examples of live vaccines include, but are not limited to, the following: measles,
mumps, rubella, varicella/zoster (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.
20. Has received therapy with a MAOI, melatonin supplement, or UGT1A9 inhibitor
within 21 days prior to starting treatment, or anticipates requiring one of these
prohibited medications during the treatment phase. Examples of medications in
these classes are found in Protocol Section 7.7 – Concomitant Therapy.
Note: Propofol, if administered for an on-study biopsy procedure, may be
permitted per Protocol Section 7.7.1.
21. Has any history of Serotonin Syndrome after receiving serotonergic drugs.
22. Has severe hypersensitivity (≥Grade 3) to study treatment (pembrolizumab and
epacadostat) and/or any of its excipients.
Prior/Concurrent Clinical Study Experience
23. Is currently participating in or has participated in a trial of an investigational
agent or has used an investigational device within 4 weeks prior to the first dose
of trial treatment.
Note: Participants who have entered the follow-up phase of an investigational
trial may participate as long as it has been 4 weeks after the last dose of the
previous investigational agent.
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1. Has disease that is suitable for local therapy administered with curative intent.
2. Has a known additional malignancy that is progressing or has required active
treatment within the past 3 years.
Note: Participants with basal cell carcinoma of the skin, squamous cell
carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer
in situ) that have undergone potentially curative therapy are not excluded.
Participants with low-risk early stage prostate cancer defined as follows are not
excluded; Stage T1c or T2a with a Gleason score ≤ 6 and prostatic-specific
antigen (PSA) < 10 ng/mL either treated with definitive intent or untreated in
active surveillance that has been stable for the past year prior to study allocation.
3. Has known active central nervous system (CNS) metastases and/or
carcinomatous meningitis. Participants with previously treated brain metastases
may participate provided they are radiologically stable, ie, without evidence of
progression for at least 4 weeks by repeat imaging, (note that repeat imaging should be performed during the study screening), clinically stable and without
requirement of steroid treatment for at least 14 days prior to first dose of study
treatment.
4. 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) is not considered a form of systemic treatment and is allowed.
5. 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.
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 known history of or is positive for active Hepatitis B (Hepatitis B surface
antigen [HBsAg] reactive) or has active Hepatitis C (HCV RNA). Note: Testing
must be performed to determine eligibility.
HBV DNA must be undetectable and HBsAg negative at screening visit.
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.
Participants who have had definitive treatment for HCV are permitted if
HCV RNA undetectable at Screening Visit.
10. Has a history of a gastrointestinal condition or procedure that in the opinion of
the Investigator may affect oral drug absorption.
11. Has a history or presence of an abnormal electrocardiogram (ECG) that, in the
investigator's opinion, is clinically meaningful. Screening corrected QT interval
(QTc) interval >480 milliseconds is excluded (corrected by Fridericia or Bazett
formula). In the event that a single QTc is >480 milliseconds, the participant
may enroll if the average QTc for the 3 ECGs is <480 milliseconds.
12. Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the trial, interfere with the
participant's participation for the full duration of the trial, or is not in the best
interest of the participant to participate, in the opinion of the treating
investigator.
13. Has known psychiatric or substance abuse disorders that would interfere with
cooperating with the requirements of the study.
14. A WOCBP who has a positive urine pregnancy test within 72 hours before
randomization (see Appendix 5). If the urine test cannot be confirmed as
negative, a serum pregnancy test is required. In such cases, the participant
must be excluded from participation if the serum pregnancy result is positive.
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.
15. Is pregnant or breastfeeding or expecting to conceive or father children within
the projected duration of the trial, starting with the screening visit through 120
days after the last dose of pembrolizumab and epacadostat/matching placebo.
Prior/Concomitant Therapy
16. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti PD-L2 agent,
IDO1 inhibitor, or with an agent directed to another stimulatory or co-inhibitory
T-cell receptor (eg, CTLA-4, OX 40, CD137), or any other antibody or drug
targeting T-cell co-stimulatory pathways in the adjuvant or advanced/metastatic
setting.
17. 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.
Note: If participant received major surgery, they must have recovered adequately
from the toxicity and/or complications from the intervention prior to starting
study treatment.
18. Has received prior radiotherapy within 2 weeks of start of trial treatment.
Participants must have recovered from all radiation-related toxicities, and not
require corticosteroids. A 1-week washout is permitted for palliative radiation
(≤2 weeks of radiotherapy) to non- CNS disease.
19. Has received a live vaccine within 30 days prior to the first dose of trial drug.
Examples of live vaccines include, but are not limited to, the following: measles,
mumps, rubella, varicella/zoster (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.
20. Has received therapy with a MAOI, melatonin supplement, or UGT1A9 inhibitor
within 21 days prior to starting treatment, or anticipates requiring one of these
prohibited medications during the treatment phase. Examples of medications in
these classes are found in Protocol Section 7.7 – Concomitant Therapy.
Note: Propofol, if administered for an on-study biopsy procedure, may be
permitted per Protocol Section 7.7.1.
21. Has any history of Serotonin Syndrome after receiving serotonergic drugs.
22. Has severe hypersensitivity (≥Grade 3) to study treatment (pembrolizumab and
epacadostat) and/or any of its excipients.
Prior/Concurrent Clinical Study Experience
23. Is currently participating in or has participated in a trial of an investigational
agent or has used an investigational device within 4 weeks prior to the first dose
of trial treatment.
Note: Participants who have entered the follow-up phase of an investigational
trial may participate as long as it has been 4 weeks after the last dose of the
previous investigational agent.
The Estimated Number of Participants
-
Taiwan
5 participants
-
Global
100 participants
