Carboplatin + Paclitaxel + Volrustomig for Head and Neck Cancers

Overseen By Clinical Trials Intake

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Chicago

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Metastatic disease, Active infection, Cardiac conditions, Autoimmune disorders, others

Stay on Your Current Meds You can continue your current medications while participating

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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination for locally advanced head and neck cancers not caused by HPV. The researchers aim to evaluate how well the drugs carboplatin, paclitaxel, and volrustomig (an experimental treatment) work together to shrink tumors before other treatments like surgery or radiation. Individuals who have not yet received treatment for their head and neck cancer and do not have distant disease spread may be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the study team to ensure they don't interfere with the trial treatments.

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

A previous study showed that paclitaxel was well-tolerated by patients with head and neck cancer, with most side effects being mild to moderate. These side effects included skin issues, mouth sores, and nerve pain, with no reports of severe reactions. Carboplatin combined with radiation therapy has also been well-tolerated in similar cancer patients, usually causing only mild side effects.

For volrustomig, safety information is less clear. Since this current trial is in Phase 2, the treatment has passed initial safety tests in smaller groups. This suggests it is safe enough for testing in larger groups, but more information is needed to fully understand its safety.

Overall, carboplatin and paclitaxel have established safety records, while volrustomig is still under study. Participants should discuss potential risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Volrustomig because it offers a novel approach to treating head and neck cancers by potentially enhancing the effects of existing chemotherapy drugs like Carboplatin and Paclitaxel. Volrustomig is administered intravenously in specific doses, both during and after radiation therapy, which might improve patient outcomes by maintaining treatment benefits over a longer period. Unlike standard treatments that mainly rely on chemotherapy and radiation, Volrustomig introduces a new active ingredient that could lead to more effective and sustained cancer control.

What evidence suggests that this trial's treatments could be effective for head and neck cancers?

This trial will evaluate the effectiveness of Carboplatin, Paclitaxel, and Volrustomig as separate treatments for head and neck cancers. Studies have shown that Paclitaxel, when combined with other treatments, can be effective in similar cancers, achieving a response rate of up to 69.6%. Research on Carboplatin suggests it can improve survival rates by 15% compared to some other treatments. Volrustomig, a newer option in this trial, demonstrated a response rate of 16% and a benefit rate of 26% in early studies, which is promising. These treatments aim to shrink tumors or halt their growth by targeting cancer cells. These findings provide hope that using these drugs in this trial could effectively treat head and neck cancers. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with untreated HPV-negative head and neck cancer that's locally advanced. Specific eligibility details are not provided, but typically participants must meet certain health standards and have no conflicting conditions.

Inclusion Criteria

Patients with non-oropharyngeal primary sites do not require testing for HPV, but if performed, must be negative

Capable of giving signed informed consent and complying with study requirements

Must have measurable disease per RECIST 1.1 criteria

Exclusion Criteria

Receiving any other investigational agents

History of allergic reactions to compounds similar to study agents

History of allogenic organ transplantation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Therapy

Participants receive neoadjuvant therapy with volrustomig, paclitaxel, and carboplatin

21-day cycles

Multiple visits for drug administration

Radiation

Participants undergo radiation therapy

Not specified

Maintenance Therapy

Participants receive maintenance volrustomig at 250mg on day 1 of a 21-day cycle for 12 cycles

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Paclitaxel
• Volrustomig

Trial Overview The study tests the effectiveness of a combination treatment using volrustomig, paclitaxel, and carboplatin in achieving a response in patients before surgery or radiation. It measures how well tumors respond to this neoadjuvant therapy.

How Is the Trial Designed?

Group I: Volrustomig Experimental Treatment 1 Intervention

Dose Level 0: 500 mg IV on day 1 of 21-day cycle Dose Level 1: 750 mg IV on day 1 of 21-day cycle After the completion of radiation, patients will be initiated on maintenance volrustomig. Volrustomig will be administered at 250mg on day 1 of a 21-day cycle for 12 cycles (36 weeks/9 months)

Group II: Paclitaxel (mg/m2) Experimental Treatment 1 Intervention

Dose Level 0: 100 mg/m2 IV on Day 1 and Day 8 of 21-day cycle Dose Level 1: 100 mg/m2 IV on Day 1 and Day 8 of 21-day cycle

Group III: Carboplatin (AUC) Experimental Treatment 1 Intervention

Dose Level 0: AUC 5 IV on day 1 of 21-day cycle Dose Level 1: AUC 5 IV on day 1 of 21-day cycle

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6853181/

Definitive Chemoradiotherapy With Carboplatin for ... Overall survival did not differ in any of the treatment comparisons, with 5- and 10-year estimates of 55% and 28% for concurrent, and 54% and 32% for radiation ...

2. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)41203-9/fulltext

Long-term outcomes with concurrent carboplatin, paclitaxel ... Treatment with concurrent carboplatin, paclitaxel and radiation is safe and offers curative potential for poor prognosis patients with locally advanced SCCHN.

3. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2796301

Cetuximab-Based vs Carboplatin ... After propensity score–based inverse probability weighting, treatment with carboplatin was associated with 15% improved overall survival ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1808869425000199

Definitive treatment in squamous cell carcinoma of head ... There was no significant difference between the CDDP and Carbo (79.7% vs. 81.2%; p = 1.00). These findings align with the ConCERT trial, which reported a RR of ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.02625

Pembrolizumab Plus Carboplatin and Paclitaxel as First- ... Pembrolizumab plus carboplatin and paclitaxel showed promising antitumor activity and a manageable safety profile in first-line R/M HNSCC.

6. ascopubs.org ascopubs.org/doi/10.1200/jco.2006.24.18_suppl.15534

Safety and efficacy of the combination carboplatin ... Stable disease was seen in 2 patients (13.3%) and progressive disease was observed in 5 pts (33.3%). Toxicity was mild: we recorded 1 case of G3 toxicity ( ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa0802656

Platinum-Based Chemotherapy plus Cetuximab in Head ... Head and neck cancer cells often express the epidermal growth factor ... Safety data were monitored by an independent data safety monitoring board.

8. spandidos-publications.com spandidos-publications.com/10.3892/ol.2022.13623

Safety and preliminary activity of pembrolizumab ... In this small retrospective series of heavily pretreated patients, pembro + CP was well tolerated, and compliance was high.

9. academic.oup.com academic.oup.com/jjco/article/45/12/1116/2384964

Safety and efficacy of concurrent carboplatin plus radiotherapy ... Concurrent carboplatin plus radiotherapy is tolerated and may be an option in treating locally advanced squamous cell carcinoma of the head and neck patients.