100 Participants NeededMy employer runs this trial

Porustobart + Pembrolizumab for Colon Cancer

Recruiting at 27 trial locations
MM
Overseen ByMedical Monitor
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether two medicines, porustobart and pembrolizumab (an immunotherapy drug), can treat microsatellite stable (MSS) colon cancer. The medicines aim to help the immune system fight the cancer before surgery. Researchers seek to determine the effectiveness of the medicines and their potential side effects. Participants will be divided into two groups, each receiving different schedules of the medicines, and must have colon cancer that can be surgically removed. This trial targets adults whose cancer hasn't spread and who can undergo surgery. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have taken an investigational agent within 3 weeks of the first dose or systemic corticosteroids within 1 week of the first dose, unless exceptions apply.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that pembrolizumab, a medicine in this trial, is generally safe. Past studies have demonstrated long-term benefits for some cancer types. Most patients tolerate it well, though some may experience side effects like tiredness, rash, or fever.

Less detailed safety information exists for porustobart, but it is being tested with pembrolizumab to enhance the immune system's fight against cancer. Since it is in a Phase 2 trial, earlier tests did not reveal major safety issues. This phase aims to provide more insight into how people react to the treatment and what side effects might occur.

In summary, pembrolizumab is generally safe, and porustobart has passed initial safety checks. Participants in this trial will help researchers understand how these drugs work together and what side effects may arise.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Porustobart combined with Pembrolizumab for colon cancer because it offers a novel approach compared to standard treatments like chemotherapy and targeted therapies. Unlike most colon cancer treatments that usually focus on either killing cancer cells directly or blocking specific growth signals, Porustobart is designed to work synergistically with Pembrolizumab, an immunotherapy drug. This combination enhances the body's immune response against cancer cells more effectively. Additionally, the varying dose schedules allow flexibility in treatment, potentially reducing side effects and improving patient outcomes.

What evidence suggests that this trial's treatments could be effective for MSS colon cancer?

Research shows that pembrolizumab helps the immune system fight cancer and effectively treats colorectal cancer. Studies have found that pembrolizumab can extend patient survival and slow disease progression in certain types of colorectal cancer. Meanwhile, porustobart, when combined with another immunotherapy, has shown promising results. In one study, nearly 35% of patients experienced tumor shrinkage, and over 60% achieved some level of disease control. This trial will test two different dosing schedules of the combination of porustobart and pembrolizumab to determine its effectiveness in patients with microsatellite stable colon cancer, which is typically more challenging to treat with immunotherapy. The goal is for this combination to shrink tumors and enhance the immune system's ability to target the cancer.678910

Are You a Good Fit for This Trial?

This trial is for adults with a type of colon cancer called microsatellite stable (MSS) that can be removed by surgery and has not spread. Participants must be healthy enough for surgery and able to receive immune-based treatments.

Inclusion Criteria

I have a tumor tissue sample and pathology report available.
Reproductive status/contraception requirements per protocol
I am 18 years old or older.
See 4 more

Exclusion Criteria

I have had severe allergic reactions to certain antibody drugs or serious lung problems.
I have not taken any experimental drugs in the past 3 weeks.
I do not need urgent surgery soon.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab and porustobart before surgery. Pembrolizumab is administered intravenously every 3 weeks for 2 doses, and porustobart is administered either once on Day 1 or twice on Day 1 and Day 22.

6-9 weeks

Surgery

Participants undergo surgical resection of the tumor 6-9 weeks after starting treatment.

1 day

Follow-up

Participants return for checkups and tests every 6 months for up to 3 years after surgery to monitor for safety and effectiveness.

3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
  • Porustobart

Trial Overview

The study tests two medicines, pembrolizumab and porustobart, given before surgery to see if they shrink MSS colon cancer. All participants get pembrolizumab; one group gets one dose of porustobart, the other gets two doses. The goal is to find the best schedule.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Dose Schedule 2 - Porustobart + PembrolizumabExperimental Treatment2 Interventions
Group II: Dose Schedule 1 - Porustobart + PembrolizumabExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Solstice Oncology, Inc.

Lead Sponsor

Citations

Porustobart/Tislelizumab Elicits Responses in MSS ...

Among 23 patients who were efficacy evaluable, the objective response rate (ORR) was 34.8%, with 8 partial the disease control rate was 60.9%, ...

The efficacy of Pembrolizumab, Ipilimumab, and Nivolumab ...

Specifically, PFS improved by 13% at 0.5 years (rising from 70.0% to 83.0%) and by 12% at 0.75 years (from 71.0% to 83.0%), which are both ...

Cancer treatment drug Keytruda helps to slow progression ...

Conclusions: In the current study, Keytruda was found to be safe and effective for treating metastatic colorectal cancer in patients with MSI-H/dMMR deficiency.

View of Pembrolizumab (Keytruda)

Keytruda extends survival, delays disease progression, and improves health-related quality of life. Approximately 20% to 25% of newly diagnosed colorectal ...

Pembrolizumab Plus Bevacizumab/CAPOX Yields ...

The 12-month progression-free survival rate was 68%, and the 24-month overall survival rate was 67%.

Regorafenib and Nivolumab or Pembrolizumab Combination ...

This study showed that the combination of regorafenib and nivolumab was associated with a modest clinical activity in patients with advanced ...

Pembrolizumab Shows Long-Term Benefits in Metastatic ...

The overall response rate (ORR) was 43.8% with pembrolizumab versus 33.1% with chemotherapy. The ORR at 24 months was also greater in the pembrolizumab arm (83 ...

Overview of Immune Checkpoint Inhibitors in Metastatic ...

What we saw there was that pembrolizumab more than doubled the PFS [progression-free survival] about 16 months vs 8 months (with chemotherapy).

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34254265/

Durable complete response to pembrolizumab in ...

In this report, we present the first case of metastatic CRC with a dramatic and durable response to pembrolizumab despite being of MSS-pMMR ...

Neoadjuvant Pembrolizumab and Porustobart in ...

This research study is looking at two medicines called Pembrolizumab and Porustobart for a common type of colon cancer. This specific type of colon cancer ...