Study of MK-7684 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (MK-7684-001)
Status: | Recruiting |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/13/2019 |
Start Date: | December 13, 2016 |
End Date: | June 3, 2022 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
A Phase 1 Trial of MK-7684 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
This is a safety, efficacy, and pharmacokinetics study of MK-7684 as monotherapy and in
combination with pembrolizumab (MK-3475) or pembrolizumab plus pemetrexed and carboplatin in
adults with metastatic solid tumors for which there is no available therapy that is expected
to convey clinical benefit. Part A of this study is a dose escalation and confirmation phase
to estimate the recommended Phase 2 dose (RPTD) for MK-7684 monotherapy or in combination
with pembrolizumab, pemetrexed, and carboplatin. Part A will also evaluate the anti-tumor
activity of MK-7684 in combination with pembrolizumab plus pemetrexed and carboplatin in
participants with non-small cell lung cancer (NSCLC) and MK-7684 (at two dose levels) in
combination with pembrolizumab in Japanese participants with gastric cancer. Part B will
evaluate the anti-tumor activity of MK-7684 at the RPTD when used as monotherapy and in
combination with pembrolizumab in participants with advanced solid tumors in a non-randomized
study design. Part B will also evaluate 2 doses of MK-7684 in combination with pembrolizumab
in participants with programmed death 1 (PD-1) treatment naïve cancer using a 1:1 randomized
study design. The primary hypothesis is that MK-7684 administered as monotherapy or in
combination with pembrolizumab is safe when administered at the RPTD.
combination with pembrolizumab (MK-3475) or pembrolizumab plus pemetrexed and carboplatin in
adults with metastatic solid tumors for which there is no available therapy that is expected
to convey clinical benefit. Part A of this study is a dose escalation and confirmation phase
to estimate the recommended Phase 2 dose (RPTD) for MK-7684 monotherapy or in combination
with pembrolizumab, pemetrexed, and carboplatin. Part A will also evaluate the anti-tumor
activity of MK-7684 in combination with pembrolizumab plus pemetrexed and carboplatin in
participants with non-small cell lung cancer (NSCLC) and MK-7684 (at two dose levels) in
combination with pembrolizumab in Japanese participants with gastric cancer. Part B will
evaluate the anti-tumor activity of MK-7684 at the RPTD when used as monotherapy and in
combination with pembrolizumab in participants with advanced solid tumors in a non-randomized
study design. Part B will also evaluate 2 doses of MK-7684 in combination with pembrolizumab
in participants with programmed death 1 (PD-1) treatment naïve cancer using a 1:1 randomized
study design. The primary hypothesis is that MK-7684 administered as monotherapy or in
combination with pembrolizumab is safe when administered at the RPTD.
Inclusion Criteria:
- For Part A Japanese cohort added with Amendment 7: Must reside in Japan and be of
Japanese descent and have adenocarcinoma of the stomach and/or gastric-esophageal
junction (GEJ) that is considered inoperable and that has received, and progressed on,
at least 1 prior chemotherapy regimen or human epidermal growth factor receptor 2
(HER2)/neu-targeted approved therapy (if HER2/neu-positive). In both cases,
participants must not have been treated with prior anti-PD-1/PD-L1 therapy
- For Part A participants with NSCLC added with Amendment 7: Must have a histologically
or cytologically confirmed diagnosis of stage IV (M1a or M1b per current AJCC
criteria, edition 8) non-squamous NSCLC
- For Parts A and B: Has histologically or cytologically confirmed metastatic solid
tumor
- Has measureable disease by Response Evaluation Criteria In Solid Tumors (RECIST)
- Has an Eastern Cooperative Oncology Group performance status of 0 to 1
- Females must not be pregnant
- Women of childbearing potential and male participants must agree to use adequate
contraception for the course of the study
- Has provided a tumor tissue sample (archival or newly obtained core or excisional
biopsy of a tumor lesion)
Exclusion Criteria:
- Has had chemotherapy, radiation, biological cancer therapy or major surgery within 4
weeks prior to the first dose of study treatment
- Has not recovered to Common Toxicity Criteria for Adverse Events Grade 1 or better
from the adverse events due to cancer therapeutics administered more than 4 weeks
prior to the first dose of study treatment
- 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 received previous treatment with another agent targeting the T cell immunoglobulin
and immunoreceptor tyrosine-based inhibitory motif (TIGIT) receptor
- Has received previous treatment with an immunomodulatory agent (e.g., anti-programmed
cell death 1/ anti-programmed cell death ligand 1 or cytotoxic T-lymphocyte-associated
protein 4) and was discontinued from that treatment due to a Grade 3 or higher
immune-related adverse event
- Is expected to require any other form of antineoplastic therapy while participating in
the trial
- Is on chronic systemic steroid therapy in excess of replacement doses or on any other
form of immunosuppressive medication.
- Has a history of a previous additional malignancy unless potentially curative
treatment has been completed with no evidence of malignancy for 5 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis
- Has an active autoimmune disease
- Has an active infection requiring systemic treatment
- Has interstitial lung disease
- Has active or past history of (non-infectious) pneumonitis requiring steroids
- Has symptomatic ascites or pleural effusion
- Has previously had a hematopoetic stem cell transplant or solid organ transplant
- Is known to be human immunodeficiency virus (HIV) positive and/or known to have active
chronic or acute Hepatitis B or Hepatitis C
- Has a known psychiatric and/or substance abuse disorder that would make it difficult
for the participant to cooperate with the requirements of the trial
- Is a regular user (including recreational use) of any illicit drugs at the time of
signing informed consent, or has a recent history (within the last year) of substance
abuse
- Has received a live-virus vaccine within 30 days prior to the first dose of study
treatment
- Has had hormonal cancer therapy (e.g., tamoxifen, leuprolide). within 4 weeks prior to
the first dose of study treatment
- For Part A participants with NSCLC added with Amendment 7: Is unable to interrupt
aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) other than an aspirin
dose ≤1.3 gram per day for a 5-day period (8-day period for long-acting agents, such
as piroxicam)
- For Part A participants with NSCLC added with Amendment 7: Is unable or unwilling to
take folic acid or Vitamin B12 supplementation
We found this trial at
11
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials