Pembrolizumab for Metastatic Colorectal Cancer (CRC)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Valkyrie Clinical Trials, Los Angeles, CA
Metastatic Colorectal Cancer (CRC)+1 More
Pembrolizumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether selinexor alone or with pembrolizumab is safe and effective in participants with advanced or metastatic colorectal cancer.

See full description

Eligible Conditions

  • Metastatic Colorectal Cancer (CRC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Metastatic Colorectal Cancer (CRC)

Study Objectives

This trial is evaluating whether Pembrolizumab will improve 1 primary outcome and 10 secondary outcomes in patients with Metastatic Colorectal Cancer (CRC). Measurement will happen over the course of At 6 Months.

12 Months
Percent Overall Survival (OS) in 12 Months for Arm A, B and C
6 Months
Percent Overall Survival (OS) in 6 Months for Arm A, B and C
At 6 Months
Progression-free Survival (PFS) at 6 Months for Arm A, B and C
Year 3
Number of Participants With Adverse Events (AEs) by Occurrence, Nature, and Severity for Arm A, B and C
Number of Participants With Clinical Significant Changes in Vital Signs, Clinical Laboratory Values, Electrocardiogram (ECG) and Physical Examination Findings for Arm A, B and C
Year 3
Progression-free Survival (PFS) Based on RECIST 1.1 for Arm A and C
Year 3
Duration of Response (DOR) Based on RECIST 1.1 for Arm A, B and C
Progression-free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for Arm B and C
Year 3
Disease Control Rate (DCR) Based on RECIST 1.1 for Arm A, B and C
Overall Response Rate (ORR) Based on RECIST 1.1 for Arm A, B and C
Overall Survival (OS) for Arm A, B and C

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Metastatic Colorectal Cancer (CRC)

Trial Design

3 Treatment Groups

Arm C: Standard of care (SOC)
1 of 3
Arm B: Selinexor 80 mg and Pembrolizumab 400 mg
1 of 3
Arm A: Selinexor 80 mg
1 of 3
Active Control
Experimental Treatment

This trial requires 78 total participants across 3 different treatment groups

This trial involves 3 different treatments. Pembrolizumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm B: Selinexor 80 mg and Pembrolizumab 400 mgParticipants will receive a single dose of 80 mg of selinexor tablets QW (4 oral tablets of 20 mg each) of selinexor oral tablets QW on Day 1 of each week (days 1, 8, 15, 22, 29, and 36) in combination with pembrolizumab 400 mg intravenously (IV) once every 6 weeks of each 42-day cycle until PD, intolerable toxicity, or withdrawal from the study.
Arm A: Selinexor 80 mg
Drug
Participants will receive a single dose of 80 milligrams (mg) of selinexor once weekly (QW) (4 oral tablets of 20 mg each) on Day 1 of each week (days 1, 8, 15, 22, 29, and 36 of each 42-day cycle) until progressive disease (PD), intolerable toxicity, or withdrawal from the study.
Arm C: Standard of care (SOC)Participants will receive combination of trifluridine and tipiracil 35 milligrams per square meter (mg/m^2) per dose (15 mg tablet + 20 mg tablet) as oral tablets twice daily (BID) (maximum 80 mg allowed per dose) as SOC on Days 1 through 5 and Days 8 through 12 of each 28-day cycle until PD, intolerable toxicity, or withdrawal from the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from the date of randomization up to death (up to 3 years)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from the date of randomization up to death (up to 3 years) for reporting.

Closest Location

Valkyrie Clinical Trials - Los Angeles, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age ≥ 18 years at the time of signing informed consent
Written informed consent signed in accordance with federal, local, and institutional guidelines.
Participants have histologically proven diagnosis of unresectable metastatic colorectal cancer with a known rat sarcoma (RAS) mutation.
Participants have measurable disease according to RECIST 1.1 criteria.
Have received 2-3 prior lines of systemic anticancer treatment (adjuvant or neoadjuvant therapy is not counted as one line of systemic therapy).
Participants with stable previously treated brain metastases are allowed.
ECOG performance status of 0-2 at the time of screening.
Life expectancy of at least 3 months.
Female participants of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male participants must use an effective barrier method of contraception if sexually active throughout the study and for 4 months after the last dose of selinexor or pembrolizumab or 6 months after trifluridine and tipiracil.

Patient Q&A Section

What causes colorectal cancer?

"Results from a recent paper suggests some factors associated with the occurrence of colorectal cancer and can be used as an indicator for the development of colorectal cancer." - Anonymous Online Contributor

Unverified Answer

What are common treatments for colorectal cancer?

"Colonoscopy with a biopsy is the gold standard for the diagnosis of colorectal cancer. The presence of symptoms does not necessarily affect the type of procedure done as a prelude to colonoscopy. If symptoms indicate a colonoscopy, then fecal occult blood testing should always be completed. If results are positive, then a colonoscopy is recommended, with biopsy if indicated by a positive result. If this is negative, then screening with colonoscopy without a biopsy is appropriate, because a positive FOBT result is a poor predictor of finding colorectal cancer at colonoscopy." - Anonymous Online Contributor

Unverified Answer

What are the signs of colorectal cancer?

"A clinical history will always be of paramount importance in the investigation of cases of colorectal cancer. The main physical features of the patient are: the type and extent of bowel disease, the appearance of adhesions, and the presence of obvious masses; and are helpful as a guide to the diagnosis and in assessing prognosis. However this cannot be relied on in isolation and further investigation is essential. These investigations include a thorough full history, rectal examination, sigmoidoscopy and flexible endoscopy; stool and blood tests including CEA, FIT and fecal genetics are also helpful. We believe that a colonoscopy is usually the study of choice in the diagnosis and staging of colorectal cancer." - Anonymous Online Contributor

Unverified Answer

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

"There is a steady increase of colorectal cancer in the United States over the last 40 or 50 years. The average number of people with colorectal cancer per year in the United States has increased from 2.3 in 1960 to 20.8 in 2013. The risk of developing colorectal cancer in the United States increased by nearly four-fold, from 1.4 per 1,000 adults per year in 1960 to 10.5 per 1,000 in 2013. The average number of colorectal cancers in the United States in 2013 was 21.9 per 100,000 adults. There was a 3:1 increase in colorectal cancer incidence in white adults over white males (19." - Anonymous Online Contributor

Unverified Answer

Can colorectal cancer be cured?

"Findings from a recent study shows that there is less than 2% residual disease in about 30% of patients who have undergone curative surgery for adenocarcinoma of the colon or rectum. However, this finding means that patients who have tumours that extended to nearby anatomic structures such as the rectum, descending colon or transverse colon may not have a 5-year survival advantage over patients with tumours localized to the colon." - Anonymous Online Contributor

Unverified Answer

What is colorectal cancer?

"Colorectal cancer is an uncommon disease. But when it occurs, it can be deadly. Colonoscelis and sigmoidoscopies are the examination of choice if there is a family history of cancer or if there is a suspicion of cancer. But as many as 85% of men undergoing colorectal cancer screenings have no evidence of cancer. Screening colonoscopy is the most important test for colorectal cancer. Colonoscopy is preferable to sigmoidoscopy because of cost, effectiveness, safety, and low complication and mortality rates for colon cancer." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in pembrolizumab for therapeutic use?

"In the therapeutic context of cancer immunotherapy, immune checkpoint blockade has been shown to be an effective treatment for cancer and this new type of immunotherapy agent illustrates how immunotherapy may be used to treat disease in which the immune system is dysfunctional." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating colorectal cancer?

"Most patients with [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) can be cured if detected early, but many patients' colon cancer develops after other types of cancer, such as lung or breast cancer. Colorectal cancer is one of the most difficult types of cancer and there are no complete treatments in a significant proportion of all cases, so the focus should be on improving the detection method of as early as possible so that a complete cure can be obtained. There should be more research on colon cancer detection, treatment and prevention strategies for a better and safe outcome. I had a bad bowel habit for several years. My colonoscopy procedure took time to get comfortable with." - Anonymous Online Contributor

Unverified Answer

Does colorectal cancer run in families?

"Results from a recent clinical trial shows, that [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) also runs in the families, similar to other cancer types. In most families colorectal cancer is not a unique cause of colorectal cancer, and further research should concentrate on its familial nature and should identify any known genetic factors for predisposition." - Anonymous Online Contributor

Unverified Answer

How serious can colorectal cancer be?

"At present there is disagreement about whether advanced stage [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) which has spread to the liver, lungs or brain is fatal or can be treated and cured, or can lead to long-term survival. However, most doctors agree that a patient with Stage II colorectal cancer is extremely unlikely, in the very least, to have been cured, or to have lived for more than a few years, if all the cancer has not spread to the lymph nodes or other parts of the body." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for colorectal cancer?

"This is a simple summary of the survival rates of [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer)s of every type and stage. Survival rates are strongly affected by the stage of the cancer and the age at onset of the disease. Survival rates also increase in individuals diagnosed at earlier stages of disease where the treatment is available. Survival ratios are useful in assessing the difference in outcomes of treatments given in different cohorts, and in comparing treatment outcomes over time." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets colorectal cancer?

"Colorectal cancer is the second leading cause of cancer deaths in the developed world. In our cohort of patients, the average age at onset of colorectal cancer was 68; the median age at diagnosis was 61. The median age of death was 65, the median age of death from the colon was 58. The 5-year survival rate was 43%. There appears to be an upturn in the incidence and mortality rates in Australia." - Anonymous Online Contributor

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