Toripalimab + Chemotherapy for Throat Cancer
(WOLF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of drugs—carboplatin or cisplatin, paclitaxel, and toripalimab (an immunotherapy)—to evaluate their safety and effectiveness in treating recurrent or metastatic throat cancer. The goal is to determine how well these treatments extend patients' lives and manage their disease. Suitable participants have throat cancer treatable with surgery and have not received prior treatment for it. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have generally shown that toripalimab is well-tolerated, though some patients have experienced side effects. One study found that 11.6% of patients stopped taking toripalimab due to side effects, compared to 4.9% of those on a placebo.
Carboplatin and cisplatin, two chemotherapy drugs used in this trial, have similar safety profiles. Cisplatin has been linked to a higher rate of difficulty swallowing, affecting 75.25% of patients in one study, though only 11.9% stopped treatment early due to side effects.
Paclitaxel, often used with carboplatin or cisplatin, has a good safety record. Common side effects, such as mouth sores and skin reactions, occurred in over half of the patients in one study.
Overall, these treatments are generally considered safe, but side effects can occur. Participants should discuss potential risks with their doctors.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for throat cancer because they combine the power of immunotherapy with traditional chemotherapy and radiation. Toripalimab, the star of this treatment approach, is an immunotherapy drug that boosts the body's own immune system to fight cancer cells, offering a potentially more targeted approach compared to standard chemotherapy alone. This combination is also unique because it tailors treatment based on patients' responses, potentially leading to more personalized and effective care. The integration of toripalimab aims to improve outcomes by enhancing the body's natural defenses, which is a promising advancement compared to conventional treatments.
What evidence suggests that this trial's treatments could be effective for throat cancer?
Research has shown that combining toripalimab with carboplatin and paclitaxel may help treat similar types of cancer. In some studies, this combination improved survival rates in esophageal cancer, which is closely related to throat cancer. Specifically, after one year, 41.9% of patients did not experience cancer progression, and 69.7% remained alive. In this trial, participants will receive toripalimab with carboplatin and paclitaxel as part of the treatment regimen. Additionally, toripalimab alone has demonstrated significant benefits in other studies. It increased the time patients lived without cancer progression from 8.2 months to 21.4 months in nasopharyngeal carcinoma, a cancer similar to throat cancer. These findings suggest that the treatments tested in this trial could be effective for throat cancer.678910
Who Is on the Research Team?
Matthew Spector, MD, FACS
Principal Investigator
UPMC Hillman Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive toripalimab, carboplatin or cisplatin, and paclitaxel every 3 weeks for two cycles
Continuation Treatment
Participants receive radiation therapy and toripalimab monotherapy for 8 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Cisplatin
- Paclitaxel
- Toripalimab
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Prior to treatment: Assessments include laryngoscopy and anatomic imaging studies Treatment: toripalimab 240mg IV with carboplatin (AUC 5) and paclitaxel (175 mg/m\^2) IV every 3 weeks for two cycles. (Cisplatin 75mg/m\^2 can be used in place of carboplatin at the investigator's discretion.) After 2 Cycles of Treatment: Repeat laryngoscopy and anatomic imaging studies. Undergo swallowing function and extranodal extension status assessment.
Patients with CR, with preoperative N0 disease or N+ disease with no extranodal extension upon neck dissection. Induction Treatment: toripalimab 240mg IV+carboplatin (AUC 5)+paclitaxel (175 mg/m\^2) IV Q Continuation Treatment: Radiation therapy as per the Intervention Description + toripalimab 240mg IV monotherapy for 8 cycles
Patients with PR ≥50% (not CR) with preserved swallowing function or CR, with preoperative N+ disease and extranodal extension upon neck dissection. Induction Treatment: toripalimab 240mg IV+carboplatin (AUC 5)+paclitaxel (175 mg/m\^2) IV Q Continuation Treatment: toripalimab 240mg IV + carboplatin (AUC 5) + paclitaxel (175 mg/m\^2) IV Q + Radiation therapy as per the Intervention Description + toripalimab 240mg IV monotherapy for 8 cycles
Find a Clinic Near You
Who Is Running the Clinical Trial?
Matthew Spector
Lead Sponsor
Coherus Oncology, Inc.
Industry Sponsor
Citations
1.
onclive.com
onclive.com/view/toripalimab-plus-chemo-maintains-survival-benefit-after-6-years-in-recurrent-metastatic-npcToripalimab Plus Chemo Maintains Survival Benefit After 6 ...
This translated to a 31-month OS improvement and a 38% reduction in risk of death (HR 0.62; 95% CI, 0.45-0.85). Taken together with the efficacy ...
Toripalimab Plus Chemotherapy for Recurrent or ...
The demonstrated progression-free survival and overall survival benefits support the use of toripalimab in combination with gemcitabine-cisplatin as the new ...
3.
targetedonc.com
targetedonc.com/view/toripalimab-combo-delivers-long-term-efficacy-in-nasopharyngeal-cancerToripalimab Combo Delivers Long-Term Efficacy in ...
This trial demonstrated a significantly improved progression-free survival (PFS) in patients with NPC receiving toripalimab. The median overall ...
Updated results of adjuvant toripalimab for locally ...
The primary end point was 2-year disease-free survival rate. Secondary end points included 2-year overall survival rate, 2-year disease specific ...
5.
cancernetwork.com
cancernetwork.com/view/toripalimab-yields-striking-pfs-improvement-in-nasopharyngeal-carcinomaToripalimab Yields 'Striking' PFS Improvement in ...
Here we see with mature follow-up that the progression-free survival went from 8.2 months [with placebo] to 21.4 months [with toripalimab].
Comparative Efficacy and Toxicity of Weekly Carboplatin ...
Both cisplatin and carboplatin demonstrated comparable complete response rates of 17 (37.8%) versus 18 (40.0%) at six weeks, 18 (40.0%) versus ...
Long-Term Outcomes of Weekly Cisplatin Versus ...
Our study suggested that those treated with weekly carboplatin and paclitaxel had no statistically significant survival and tumor control ...
Survival outcomes in patients with oropharyngeal cancer ...
Phase II trials have demonstrated 2-year overall survival of 66.6 % for stage III/IV resectable oro/hypopharyngeal treated with cisplatin, ...
NCT05491512 | A Study of Reduced Radiation Therapy ...
The purpose of this study is to find out if lower doses of radiation may help reduce the side effects of radiation therapy in combination with ...
Cisplatin Versus Carboplatin and Paclitaxel in ...
The results showed planned RCT completion in 59.0% of cases in the cisplatin group compared with 73.0% in the carboplatin group (9). In contrast to these ...
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