MK-4830 for Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
University General Hospital of Heraklion ( Site 0110), Heraklion, Greece
MK-4830 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether a drug may help treat cancer.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether MK-4830 will improve 5 primary outcomes and 4 secondary outcomes in patients with Cancer. Measurement will happen over the course of Cycle 1 (Up to 21 days).

Month 25
Number of Participants Positive for Anti-Drug Antibodies (ADA) After MK-4830 plus Pembrolizumab Treatment
Month 25
Area Under the Curve (AUC) of Plasma MK-4830
Maximum Drug Concentration (Cmax) of Plasma MK-4830
Minimum Drug Concentration (Cmin) of Plasma MK-4830
Day 21
Dose-Limiting Toxicities (DLTs)
Month 24
Number of Participants Who Discontinued Study Treatment Due to an AE
ORR per Modified RECIST (mRECIST) 1.1 as Assessed by Investigator
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or Response Assessment in Neuro-Oncology (RANO) as Assessed by Investigator
Month 27
Number of Participants Who Experienced an Adverse Event (AE)

Trial Safety

Safety Estimate

1 of 3

Trial Design

17 Treatment Groups

No Control Group
Dose Expansion, Arm A: Pancreatic Adenocarcinoma

This trial requires 442 total participants across 17 different treatment groups

This trial involves 17 different treatments. MK-4830 is the primary treatment being studied. Participants will be divided into 17 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Dose Expansion, Arm A: Pancreatic AdenocarcinomaCombination therapy with the preliminary recommended phase 2 dose (RP2D) A of MK-4830, and pembrolizumab, in participants with histologically or cytologically confirmed pancreatic adenocarcinoma. MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years).
Dose Expansion, Arm D: PD-L1 positive HNSCC, Dose ACombination therapy with the preliminary RP2D A of MK-4830, and pembrolizumab, in participants who have histologically or cytologically-confirmed advanced programmed death-ligand 1 (PD-L1) positive head and neck squamous cell carcinoma (HNSCC). MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years).
Dose Expansion, Arm L: MesotheliomaTriple combination therapy with pembrolizumab plus preliminary RP2D A of MK-4830 plus pemetrexed plus cisplatin in participants who have histologically confirmed advanced mesothelioma. MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1 for a maximum of 35 cycles (up to approximately 2 years). Each cycle is 21 days. Pemetrexed will be administered by IV, on Day 1 of each Q3W cycle for a maximum of 6 cycles. Each cycle is 21 days. Cisplatin will be administered by IV, on Day 1 of each Q3W cycle for a maximum of 6 cycles. Each cycle is 21 days.
Dose Expansion, Arm F: First-Line Advanced NSCLC, Dose BCombination therapy with the preliminary RP2D B of MK-4830, and pembrolizumab, in participants who have histologically-confirmed, first-line treatment advanced non-small-cell-lung-cancer (NSCLC) (Stage IIIB or IV). MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years).
Dose Expansion, Arm J: Ovarian CancerTriple combination therapy with pembrolizumab plus preliminary RP2D A of MK-4830 plus paclitaxel in participants who have histologically confirmed, ovarian cancer. MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1 for a maximum of 35 cycles (up to approximately 2 years). Each cycle is 21 days. Paclitaxel will be administered by IV, once every week (QW) on Days 1, 8, and 15 of each 21-day cycle until disease progression or prohibitive toxicity.
Dose Expansion, Arm M: Advanced Solid Tumor in Chinese Participants In ChinaCombination therapy with the preliminary RP2D A of MK-4830, and pembrolizumab, in Chinese participants, who reside in China, have histologically or cytologically-confirmed advanced/metastatic solid tumor, and who have been previously treated with at least 2 prior lines of therapy. MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years).
Dose Escalation, Part A: MK-4830 Monotherapy
Drug
MK-4830 monotherapy (with MK-4830 doses determined by an accelerated titration design [ATD]) will be administered intravenously (IV), every 3 weeks (Q3W), starting with Cycle 1, Day 1, for a maximum of 35 cycles (up to approximately 2 years). Each cycle is 21 days. Participants enroll with histologically or cytologically confirmed pancreatic adenocarcinoma.
Dose Escalation, Part C: MK-4830 and PembrolizumabCombination therapy with MK-4830 and pembrolizumab (with MK-4830 doses determined by an mTPI design). MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years).
Dose Expansion, Arm B: Glioblastoma (GBM)Combination therapy with the preliminary RP2D A of MK-4830, and pembrolizumab, in participants with histologically or cytologically confirmed GBM. MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years).
Dose Expansion, Arm C: R/M HNSCCCombination therapy with the preliminary RP2D A of MK-4830, and pembrolizumab, in participants who have histologically or cytologically-confirmed recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) whose disease progressed on an anti-programmed cell death 1/programmed cell death ligand 1 (PD1/L1) therapy. MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years).
Dose Expansion, Arm G: NSCLC, +Carboplatin/PemetrexedCombination therapy with the preliminary RP2D A of MK-4830, pembrolizumab, and carboplatin/pemetrexed in participants with advanced non-squamous non-small-cell-lung-cancer (NSCLC) (Stage IIIB or IV). MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles. Carboplatin and pemetrexed will be administered IV Q3W, starting with Cycle 1, Day 1, for 4 cycles, followed by pemetrexed Q3W continuous with MK-4830 and pembrolizumab, up to 35 cycles. Each cycle is 21 days (up to approximately 2 years).
Dose Expansion, Arm I: R/M Gastric/GE Junction AdenocarcinomaCombination therapy with the preliminary RP2D A of MK-4830, and pembrolizumab, in participants who have histologically or cytologically-confirmed recurrent or metastatic (R/M) gastric or gastroesophageal (GE) junction adenocarcinoma and who have been previously treated with at least 2 prior lines of therapy. MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years).
Coformulation Phase, Arm N: MK-4830A (Coformulation of MK-4830 + pembrolizumab)
Biological
Monotherapy with MK-4830A, a coformulation of MK-4830 800 mg + pembrolizumab 200 mg, in participants with histologically or cytologically-confirmed advanced/metastatic solid tumor, and who and have received, been intolerant to, been ineligible for, or refused all treatment known to confer clinical benefit. MK-4830A will be administered IV, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles (up to approximately 2 years). Each cycle is 21 days.
Dose Escalation, Part B: MK-4830 Monotherapy
Drug
MK-4830 monotherapy (with MK 4830 doses determined by a modified toxicity probability interval [mTPI] method) will be administered IV, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles (up to approximately 2 years). Each cycle is 21 days. Participants enroll with histologically or cytologically confirmed pleural or peritoneal malignant mesothelioma, epithelial, sarcomatoid, or biphasic subtypes.
Dose Expansion, Arm E: First-Line Advanced NSCLC, Dose ACombination therapy with the preliminary RP2D A of MK-4830, and pembrolizumab, in participants who have histologically-confirmed, first-line treatment advanced non-small-cell-lung-cancer (NSCLC) (Stage IIIB or IV). MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years).
Dose Expansion, Arm H: RCC, +LenvatinibCombination therapy with the preliminary RP2D A of MK-4830, pembrolizumab, and lenvatinib in participants with advanced renal cell carcinoma (RCC). MK-4830 will be administered IV, Q3W, starting with Cycle 1 following pembrolizumab infusion, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1. Each cycle is 21 days. The combination may be administered for a maximum of 35 cycles (up to approximately 2 years). Lenvatinib will be administered orally once daily for up to 35 cycles of 21 days (up to approximately 2 years).
Dose Expansion, Arm K: Triple negative Breast Cancer (TNBC)Triple combination therapy with pembrolizumab plus preliminary RP2D A of MK-4830 plus paclitaxel in participants who have histologically confirmed TNBC. MK-4830 will be administered IV following pembrolizumab infusion, Q3W, starting with Cycle 1, Day 1, for a maximum of 35 cycles. Each cycle is 21 days. Pembrolizumab will be administered by IV, Q3W, starting with Cycle 1, Day 1 for a maximum of 35 cycles (up to approximately 2 years). Each cycle is 21 days. Paclitaxel will be administered by IV on Days 1, 8, and 15 every 4 weeks (Q4W) until disease progression or prohibitive toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Pembrolizumab
FDA approved
Pemetrexed
FDA approved
Lenvatinib
FDA approved
Paclitaxel
FDA approved
Cisplatin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 27 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to approximately 27 months for reporting.

Closest Location

Washington University ( Site 0003) - Saint Louis, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 2 prior treatments for Cancer. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Has a solid tumor by pathology report and has received, has been intolerant to, or has been ineligible for all treatment known to confer clinical benefit show original
You have measurable disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1. show original
Submits an evaluable baseline tumor sample for analysis (either a recent or archival tumor sample). This inclusion criterion does not apply to Expansion phase Arm M
You have a discrete malignant lesion that is amenable to biopsy. show original
You have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale show original
Demonstrates adequate organ function
You are a male and you agree to use an approved contraception(s) during the treatment period and for at least 180 days after the last dose of study treatment and you will not donate sperm during this period. show original
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and either not a woman of childbearing potential (WOCBP) OR if a WOCBP agrees to follow the study contraceptive guidance during the treatment period and for at least 180 days after the last dose of study treatment
You have histologically or cytologically confirmed metastatic pancreatic adenocarcinoma. show original
You have received at least 1 prior line of therapy and no more than 3 prior lines of systemic therapy. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of cancer?

Add answer

The symptom list of the WHO FACT-G, which is used to examine cancer-related symptoms in patients, can be used to screen for symptom patterns for many types of cancer, and can be used to screen for symptoms in particular cancers when this seems necessary.

Unverified Answer

What causes cancer?

Add answer

The leading cause of cancer is cigarette smoking. The main reason you are unlikely to get cancer unless you smoke is that you are a bad smoker with a slow metabolism, and it takes too long for the cancer to develop. The reason you get a slow metabolising cancer (squamous cell carcinoma) rather than an instant cancer can be traced to many variables, notably; the hormones that cause you to be a smoker - estrogen and progesterone causing the lining of the lungs to become cancerous - but most importantly - a high concentration of one of these hormones that can be seen in the smoke from your cigarette - the hormone known as Hormone Insensitive Isoseismic (H2I2) – see next section.

Unverified Answer

Can cancer be cured?

Add answer

Approaches used in curing cancer must be validated cautiously to prevent possible side effects. Also, because the disease model used in cancer research is not always relevant to patients, it can be difficult to test new therapeutic mechanisms that are currently being studied in clinical trials.

Unverified Answer

What are common treatments for cancer?

Add answer

The common treatments for cancer are chemotherapy, radiation, surgery, and targeted therapy. In the next few years, epigenetic therapy will also come into play. There are many different ways to treat a certain type of cancer, but chemotherapy is the most used treatment and is best at treating a few types on cancer. The other treatments that chemotherapy affects a lot include remission, survival, and how much cancer is left. There is also a lot of chemotherapy to help a person fight metastatic cancer, which is when cancer has spread beyond the primary tumor. The treatments a person gets depend on the cancer type they have.

Unverified Answer

What is cancer?

Add answer

The prevalence of cancer in a population has been substantially underestimated. Nearly 30 million people were diagnosed with cancer in 2001-2004 in the UK, and there was at least one case of cancer diagnosed in nearly 60% of adults. More than two thirds of all cancer diagnoses are caused by curable tumours, and about half of these cancers can be prevented, by simple measures like smoking cessation, quitting by menopausal age, stopping drinking alcohol early, and regular blood pressure checks.

Unverified Answer

How many people get cancer a year in the United States?

Add answer

The five leading causes of cancer deaths in the United States are lung cancer (7,067), pancreatic cancer (4,822), colon cancer (4,731), prostate cancer (3,903), and breast cancer (3,835). The leading causes of cancer deaths among those ages 79 years old and older are colorectal cancer (5,824), lung cancer (5,821), liver cancer (5,768), prostate cancer (5,743), and breast cancer (5,847). Lung cancer causes the most cancer-related deaths among Americans of all ages as well as among whites and Hispanics, and has the highest incidence among white men.

Unverified Answer

Have there been any new discoveries for treating cancer?

Add answer

There was great controversy when this question was raised. No one could provide a conclusive answer. A better answer to this is we are getting better at finding new treatments and strategies, but there is no 'one best' approach when it comes to treating cancer. Treating cancer is the best we can do. There should never be one 'right' treatment for cancer. What is 'right' is based on each patient's tumor, the health of the patients themselves and their ability to tolerate these treatments.

Unverified Answer

Has mk-4830 proven to be more effective than a placebo?

Add answer

Results from a recent paper suggest only a modest effect of MK-4830 on the symptoms of breast cancer. They are not sufficiently statistically significant to justify MK-4830's marketing in this unselected cohort because the study was not powered to detect treatment effects of moderate magnitude.

Unverified Answer

Does mk-4830 improve quality of life for those with cancer?

Add answer

In the setting of cancer, MK-4830 treatment provides short-term improvements in a person's QoL in a dose-dependent manner. MK-4830 does not appear to have a substantial adverse impact on the QoL of patients with cancer.

Unverified Answer

What are the common side effects of mk-4830?

Add answer

The common side effects include rash, mild rash, itchiness, swelling of the lips, tongue, and the palms of the hands. People should seek medical advice if these symptoms persist after taking mk-4830 and contact the manufacturer or the responsible national regulatory authority.

Unverified Answer

What is the average age someone gets cancer?

Add answer

The population-based cancer incidence rate is generally increasing for men and stable for women. Nevertheless, there is still wide variation between countries, and in some countries, the male to female ratio may be increasing. In addition, the average age of onset for most cancers is higher in some nations than others, probably driven by risk factor pattern. On the basis of global trends for cancer incidence and mortality, we estimate that cancers of the colon, lung and breast are the most important types, for which the life expectancy at age 40 years is more than 10 years greater than for men and women, respectively.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Cancer by sharing your contact details with the study coordinator.