CADI-05 + Pembrolizumab for Head and Neck Cancer

Recruiting at 1 trial location

Overseen By Jianli Hu, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Fox Chase Cancer Center

Must not be taking: Immunosuppressants, Investigational agents

Disqualifiers: Autoimmune disorders, Uncontrolled infections, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 6

Duration: 5 weeks

22 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding CADI-05, an experimental treatment, to pembrolizumab, a cancer immunotherapy, can enhance treatment for locally advanced head and neck squamous cell carcinoma. Researchers aim to determine if this combination strengthens the immune system's ability to combat cancer and to identify any side effects. It suits individuals with specific types of head and neck cancer who plan to undergo surgery and have not received recent cancer treatments. Participants will receive treatments and checkups weekly for five weeks, followed by surgery and a follow-up visit.

As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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

Previous studies have shown that pembrolizumab has a manageable safety profile, meaning side effects can occur but are usually tolerable. Common side effects include fatigue and nausea, often mild. The FDA has already approved pembrolizumab for treating certain cancers, suggesting it is generally safe when used as directed.

Reports indicate that CADI-05 is mostly safe, with minor side effects like redness and swelling at the injection site. Occasionally, a slight fever may occur. These reactions are usually not serious and tend to resolve on their own.

As this is a Phase 1 trial, it marks the first time CADI-05 is being tested in people for this specific use. This phase focuses on assessing the treatment's safety and determining the best dose. While pembrolizumab has a known safety profile, researchers are still studying CADI-05 to better understand its safety when used with pembrolizumab. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for head and neck cancer?

Most treatments for head and neck cancer, like surgery, radiation, and chemotherapy, aim to remove or kill cancer cells directly. But CADI-05, used with pembrolizumab, works differently by boosting the immune system's ability to fight cancer. Researchers are excited about this combination because it might enhance the effectiveness of pembrolizumab, an immunotherapy drug that helps T-cells target and destroy cancer cells. This approach could offer a more targeted attack on the cancer, potentially leading to better outcomes with fewer side effects compared to traditional treatments.

What evidence suggests that CADI-05 combined with pembrolizumab might be an effective treatment for head and neck cancer?

Studies have shown that pembrolizumab, a type of immunotherapy, can help patients with advanced head and neck cancer live longer. Research suggests that pembrolizumab enables the immune system to find and attack cancer cells more effectively. Specifically, it has worked in about 24.8% of patients with cancer that has returned or spread. In this trial, participants will receive a combination of CADI-05 and pembrolizumab to evaluate whether CADI-05 can enhance pembrolizumab's effectiveness. Although limited data exists on CADI-05, it may strengthen the immune system's ability to fight cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Parth Desai

Principal Investigator

Fox Chase Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

My bone marrow, liver, and kidneys are working well.

I have head and neck squamous cell cancer that has come back or is a new tumor, and I am planning to have surgery.

I have a new, confirmed diagnosis of resectable, non-metastatic squamous cell carcinoma.

Exclusion Criteria

I do not have another active cancer, except for certain allowed types.

I have used immunosuppressive medication in the past 14 days.

I have untreated or active hepatitis B or C.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab by IV on day 1 of week 1 and again on day 1 of week 4, and CADI-05 as a small injection into the skin once a week for 5 weeks

5 weeks

5 visits (in-person)

Surgery

Participants undergo surgery between week 6 and week 7

1 week

Follow-up

Participants return to the clinic once for a follow-up visit about 30 days after surgery

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CADI-05
• Pembrolizumab

How Is the Trial Designed?

Group I: Treatment with CADI-05 and pembrolizumab Experimental Treatment 2 Interventions

the neoadjuvant CADI-05 with pembrolizumab

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

Cadila Pharnmaceuticals

Industry Sponsor

Trials

13

Recruited

15,600+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07455032

Study Details | NCT07455032 | Neoadjuvant CADI-05 in ...

The main questions it aims to answer are: Does using CADI-05 together with pembrolizumab help the immune system fight cancer better and lead to better results ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12840263/

Clinical Outcomes of Pembrolizumab in Head and Neck ...

This study is the first to demonstrate the potential efficacy and safety of pembrolizumab in patients with tumors in subsites excluded from ...

3.

adisinsight.springer.com

adisinsight.springer.com/trials/700391223

Neoadjuvant CADI-05 in Combination With Pembrolizumab ...

The goal of this clinical trial is to learn if drug CADI-05, when used together with pembrolizumab (an FDA approved immunotherapy), ...

4.

onclive.com

onclive.com/view/pembrolizumab-plus-chemo-elicits-responses-in-head-and-neck-squamous-cell-carcinoma

Pembrolizumab Plus Chemo Elicits Responses in Head ...

The first-line combination of pembrolizumab (Keytruda), carboplatin, and paclitaxel demonstrated antitumor activity and a manageable toxicity profile

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12476047/

Pembrolizumab as first-line treatment for recurrent or ... - PMC

Pembrolizumab is frequently used for recurrent or metastatic head and neck squamous cell carcinoma (rmHNSCC) as first-line treatment.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38043938/

Safety outcomes of pembrolizumab with platinum agent ...

This study helps to characterize the safety profile and activity of pembrolizumab in combination with a platinum agent and taxane derivative ...

7.

frontiersin.org

frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1348045/full

Real-world use of first-line pembrolizumab + platinum + ...

This was a retrospective study of US adults ≥18 years of age receiving pembrolizumab + platinum + taxane as 1L treatment for R/M HNSCC.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11590380/

Safety outcomes of pembrolizumab with platinum agent ... - PMC

This study helps to characterize the safety profile and activity of pembrolizumab in combination with a platinum agent and taxane derivative in HNSCC patients.