Duvelisib + Docetaxel for Head and Neck Cancer

Overseen By Glenn J. Hanna, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Glenn J. Hanna

Must not be taking: PI3K inhibitors, CYP3A inducers

Disqualifiers: CNS metastases, Carcinomatous meningitis, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 22

Duration: 24 months

26 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of a pill (Duvelisib) and an IV drug (Docetaxel) for patients with head and neck cancer that has come back or spread. These patients did not respond to initial treatments. Duvelisib stops cancer cells from growing, and Docetaxel kills them by preventing cell division.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take medications or foods that strongly affect a liver enzyme called CYP3A within 2 weeks of starting duvelisib or during the study.

What data supports the effectiveness of the drug combination Duvelisib and Docetaxel for head and neck cancer?

Research shows that Docetaxel, when used with other drugs like cisplatin, has been effective in treating head and neck cancer, with response rates of 33% to 44% and improved survival. This suggests that combining Docetaxel with other drugs, like Duvelisib, could potentially be effective as well. ^{1 2 3 4 5}

What safety data exists for the treatment of Duvelisib + Docetaxel in humans?

Docetaxel, one of the drugs in the combination, has been studied for safety in head and neck cancer. It has been found to be generally safe, but like many cancer treatments, it can have side effects, which may include low blood cell counts, fatigue, and nausea. There is no specific safety data available for the combination of Duvelisib and Docetaxel in humans. ^{1 4 5 6 7}

What makes the drug combination of Duvelisib and Docetaxel unique for head and neck cancer?

The combination of Duvelisib and Docetaxel for head and neck cancer is unique because it pairs a targeted therapy (Duvelisib, which affects specific pathways in cancer cells) with a chemotherapy drug (Docetaxel, which disrupts cell division), potentially offering a novel approach compared to traditional chemotherapy regimens that often include drugs like cisplatin and 5-fluorouracil. ^{1 2 3 4 5}

Research Team

Glenn J. Hanna, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Adults with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), who have had no more than two prior systemic therapies, one including PD-1/L1 blockade. They must not have used PI3K inhibitors before, be in good health otherwise, and agree to use contraception.

Inclusion Criteria

I am 18 years old or older.

My blood, liver, and kidney functions meet the study's health requirements.

I can provide information on my tumor's PD-L1 and HPV status.

Exclusion Criteria

I have cancer that has spread to my brain or spinal cord.

I have not taken strong CYP3A affecting drugs or foods within 2 weeks of starting duvelisib.

I am not taking any other cancer treatments or experimental drugs during this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive duvelisib orally twice daily and docetaxel via IV on day 1 of each 21-day cycle for up to 24 months

24 months

Every 21 days (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Regular follow-up visits

Treatment Details

Interventions

• Docetaxel
• Duvelisib

Trial Overview The trial is testing duvelisib combined with docetaxel chemotherapy in patients with SCCHN that has returned or spread. Duvelisib is a PI3K inhibitor which may help stop cancer growth by targeting specific cells.

Participant Groups

Group I: Duvelisib plus Docetaxel chemotherapy Experimental Treatment 2 Interventions

Participants will receive duvelisib by mouth twice daily,dosage per protocol continuously (days 1-21 of a 21-day cycle) with a 7-day lead-in planned prior to the start of taxane therapy. Docetaxel at via IV will be delivered on day 1 of each 21-day cycle. Treatment will continue for 24-months or until unacceptable toxicity, progression, or death.

Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in European Union as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Canada as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Japan as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Who Is Running the Clinical Trial?

Glenn J. Hanna

Lead Sponsor

Trials

6

Recruited

160+

Secura Bio, Inc.

Industry Sponsor

Trials

9

Recruited

200+

Findings from Research

In a phase I/II trial involving 22 patients with recurrent/metastatic head and neck cancer, the combination of docetaxel and pembrolizumab showed a 22.7% overall response rate, indicating potential efficacy in this difficult-to-treat population.

The treatment was associated with manageable side effects, with myelosuppression being the most common adverse event, while serious immune-related side effects were relatively rare, suggesting a favorable safety profile for this combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab plus docetaxel for the treatment of recurrent/metastatic head and neck cancer: A prospective phase I/II study. Fuereder, T., Minichsdorfer, C., Mittlboeck, M., et al.[2023]

In a phase III study involving 358 patients with advanced head and neck cancer, adding docetaxel to cisplatin and 5-fluorouracil (TPF) improved overall survival and reduced toxicity compared to the PF regimen.

Patients receiving TPF showed a trend towards better health-related quality of life (HRQOL) and experienced greater improvements in swallowing and coughing issues during treatment, suggesting that TPF may enhance patient well-being alongside survival benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term health-related quality of life and symptom control with docetaxel, cisplatin, 5-fluorouracil and cisplatin (TPF), 5-fluorouracil (PF) for induction in unresectable locoregionally advanced head and neck cancer patients (EORTC 24971/TAX 323). van Herpen, CM., Mauer, ME., Mesia, R., et al.[2022]

Docetaxel shows promising efficacy as a treatment for recurrent squamous cell cancer of the head and neck, with response rates between 33% to 44% when combined with cisplatin, and median survival times of 9.6 to 11 months.

In the neoadjuvant setting, docetaxel has demonstrated response rates greater than 90%, indicating its potential for improving disease-free and overall survival, with ongoing trials comparing its effectiveness to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of docetaxel in the management of squamous cell cancer of the head and neck. Glisson, BS.[2018]

In a phase II study involving 31 patients with advanced squamous cell carcinoma of the head and neck, docetaxel demonstrated significant activity, with a major response rate of 42% and a median response duration of 5 months.

Docetaxel was well tolerated, with manageable side effects such as leukopenia and fatigue, and the use of premedication helped reduce the incidence of severe toxicities, allowing for safe outpatient administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel: an active drug for squamous cell carcinoma of the head and neck. Dreyfuss, AI., Clark, JR., Norris, CM., et al.[2018]

The combination of docetaxel and cisplatin demonstrated a significant overall response rate of 53.7% in patients with locally advanced, recurrent, or metastatic squamous cell carcinoma of the head and neck, indicating its efficacy as a treatment option.

Despite common hematologic and non-hematologic toxicities, the treatment was generally well-tolerated, with serious adverse effects being infrequent due to the use of corticosteroid prophylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel and cisplatin: an active regimen in patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck. Results of a phase II study of the EORTC Early Clinical Studies Group. Schöffski, P., Catimel, G., Planting, AS., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Pembrolizumab plus docetaxel for the treatment of recurrent/metastatic head and neck cancer: A prospective phase I/II study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Short-term health-related quality of life and symptom control with docetaxel, cisplatin, 5-fluorouracil and cisplatin (TPF), 5-fluorouracil (PF) for induction in unresectable locoregionally advanced head and neck cancer patients (EORTC 24971/TAX 323). [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The role of docetaxel in the management of squamous cell cancer of the head and neck. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Docetaxel: an active drug for squamous cell carcinoma of the head and neck. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Docetaxel and cisplatin: an active regimen in patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck. Results of a phase II study of the EORTC Early Clinical Studies Group. [2020]

6. Greece pubmed.ncbi.nlm.nih.gov

Dose-finding study of docetaxel added to ifosfamide and cisplatin followed by concomitant capecitabine and radiotherapy in the treatment of locally advanced squamous cell carcinoma of the head and neck. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

An in vivo evaluation of docetaxel delivered intratumorally in head and neck squamous cell carcinoma. [2018]