Pembrolizumab for Skin Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of pembrolizumab in treating advanced skin sarcomas, rare cancers affecting the skin or underlying tissue. Participants will receive pembrolizumab, an immunotherapy drug, through an IV infusion every three weeks to assess its effectiveness. Suitable candidates for this trial include individuals with advanced or metastatic cutaneous sarcomas, particularly if the cancer has recurred or spread and cannot be surgically removed without significant health risks. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must be at least 4 weeks from prior systemic anti-cancer therapy and 2 weeks from prior radiotherapy before starting the study treatment.
Is there any evidence suggesting that pembrolizumab is likely to be safe for humans?
Research has shown that pembrolizumab is generally well-tolerated, meaning most patients can handle it without serious issues. Studies have found its side effects manageable, indicating they are acceptable and controllable. In past studies, patients with recurrent or metastatic cutaneous squamous cell carcinoma experienced lasting positive results without new safety concerns. The treatment did not cause any new or unexpected side effects over time.
The FDA has already approved pembrolizumab for certain skin cancers, especially when surgery or radiation isn't an option. This approval indicates the treatment is considered safe for these situations. Overall, many patients have used pembrolizumab, and it is regarded as safe with known and manageable side effects.12345Why do researchers think this study treatment might be promising?
Pembrolizumab is unique because it works by targeting the PD-1 pathway, a mechanism that helps the immune system recognize and attack cancer cells. This is different from traditional treatments like chemotherapy, which attack cancer cells directly but can also harm healthy cells. Researchers are excited about pembrolizumab because it can offer a more targeted approach, potentially leading to fewer side effects and improved effectiveness in treating skin cancer. This immune-based strategy could represent a significant advancement in how we approach cancer therapy.
What evidence suggests that pembrolizumab might be an effective treatment for advanced cutaneous sarcomas?
Research has shown that pembrolizumab, also known as KEYTRUDA, yields promising results in treating certain skin cancers. In studies with patients who had advanced melanoma, more than one-third survived ten years after treatment. Additionally, pembrolizumab effectively shrank tumors in 89% of patients with rare skin cancers, with many experiencing quick improvements. Overall, pembrolizumab has demonstrated a strong ability to control cancer growth and improve survival rates for various skin cancers. These findings suggest it could also be effective for advanced cutaneous sarcomas. Participants in this trial will receive pembrolizumab as part of the study treatment.678910
Who Is on the Research Team?
Andrew Brohl, MD
Principal Investigator
Moffitt Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with advanced cutaneous sarcomas, a type of skin cancer. It's open to all races, ethnicities, and genders. However, it excludes those with angiosarcoma.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Pembrolizumab 200 mg administered as 30-minute IV infusion every 21 days (3 weeks)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
Trial Overview
The study tests pembrolizumab effectiveness in treating advanced cutaneous sarcomas. Around 17 patients will receive pembrolizumab through an IV every three weeks.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Pembrolizumab 200 mg will be administered as 30-minute IV infusion every 21 days (3 weeks).
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Citations
Ten-Year Data for Merck's KEYTRUDA® (pembrolizumab ...
At 10 years, more than one-third (34.0%) of patients with advanced melanoma were alive after treatment with KEYTRUDA, compared to 23.6% of patients treated ...
Long-Term Data From Patients Who Received ...
We present four cases in which the immune checkpoint inhibitor pembrolizumab was given to patients with advanced CSCC.
KEYNOTE-006 - Clinical Trial Results | HCP - Keytruda
Median OS at 22.9-month median follow-up was not reached with KEYTRUDA vs 16 months (95% CI, 13.5–22.0) with ipilimumab.1. a. From product-limit (Kaplan-Meier) ...
4.
uclahealth.org
uclahealth.org/news/release/immunotherapy-helps-extend-lives-patients-with-rare-formImmunotherapy helps extend the lives of patients with rare ...
Overall, 89% of patients experienced tumor shrinkage or disappearance. Importantly, the responses were often rapid, with some patients seeing ...
Immunotherapy for Skin Cancer: Types, Success Rate, ...
In the adjuvant setting, pembrolizumab has demonstrated efficacy. A phase III study showed that pembrolizumab improved the 1-year recurrence- ...
Pembrolizumab for the Treatment of Locally Advanced ...
Pembrolizumab, approved by the FDA in 2020 for recurrent or metastatic cSCC not amenable to curative surgery or radiation, has shown promising results in ...
Pembrolizumab for locally advanced and recurrent ...
Pembrolizumab demonstrated clinically meaningful and durable antitumor activity with a manageable safety profile in recurrent/metastatic (R/M) cutaneous ...
Long-term results of the phase 2 KEYNOTE-629 study.
With a median follow-up of more than 5 years, pembro continued to show durable responses in pts with LA or R/M cSCC. No new safety signals were observed.
Safety profile of pembrolizumab monotherapy based on an ...
Pembrolizumab has a manageable safety profile as described in its label, which was primarily based on 2799 patients who participated in ...
Phase 3 randomized trial (KEYNOTE-630) of adjuvant ...
The safety profile of adjuvant pembro was consistent with reports from similar studies and there were no treatment-related deaths. The study was stopped for ...
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