Toripalimab + Chemotherapy for Oropharyngeal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for individuals with a specific type of throat cancer linked to HPV16, a virus that can cause cancer in the throat area. Researchers aim to assess the effectiveness of toripalimab, an immunotherapy drug, when combined with chemotherapy before other treatments like surgery and possibly radiation. The study seeks participants diagnosed with HPV16-positive oropharyngeal cancer who have not previously undergone chemotherapy or radiation for head and neck cancer. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer care.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive medications or herbal remedies with immune-stimulating properties, you may need to stop them before starting the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that toripalimab, when combined with chemotherapy, offers promising safety results for patients with various types of cancer. One study found that 11.6% of patients taking toripalimab stopped treatment due to side effects, compared to 4.9% of those on a placebo. While some patients may experience side effects, the treatment is generally well-tolerated.
Toripalimab, when used with chemotherapy for other cancers, significantly improved patient survival. This suggests that the combination is both effective and manageable for many patients.
This study is in Phase 2, indicating that toripalimab has already passed initial safety tests. The treatment is considered safe enough for a larger group of participants. However, patients should be aware of possible side effects and discuss them with a healthcare provider.12345Why do researchers think this study treatment might be promising for oropharyngeal cancer?
Toripalimab is unique because it is an immunotherapy that works by targeting the PD-1 protein on immune cells, which helps the immune system recognize and attack cancer cells more effectively. This is different from traditional treatments for oropharyngeal cancer, like chemotherapy and radiation, which directly target and kill cancer cells but can also harm healthy cells. Researchers are excited about toripalimab because it has the potential to enhance the body's natural defense mechanisms, offering a more targeted and potentially less harmful approach to treating cancer.
What evidence suggests that the combination of toripalimab and chemotherapy could be an effective treatment for oropharyngeal cancer?
Research has shown that combining toripalimab with chemotherapy holds promise for treating nasopharyngeal cancers, which are similar to oropharyngeal cancers. Studies have found that this combination can significantly increase overall survival, extending it by 31 months compared to chemotherapy alone. Another study found it reduced the risk of death by 37% in patients with nasopharyngeal cancer. Additionally, toripalimab has improved progression-free survival, meaning the cancer does not worsen for a longer time. In this trial, participants will receive toripalimab with neoadjuvant chemotherapy to evaluate its effectiveness in treating HPV16+ locoregionally advanced oropharyngeal cancer.12678
Who Is on the Research Team?
Ari Rosenberg
Principal Investigator
University of Chicago
Are You a Good Fit for This Trial?
This trial is for adults with HPV16-positive throat cancer, specifically squamous cell carcinoma of the oropharynx. Participants must have certain levels of tumor size and nodal disease, be in good physical condition (ECOG 0-1), and not have had previous radiation or chemotherapy for head and neck cancer. Complete surgical resection should not have been done within 8 weeks before joining.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive toripalimab with neoadjuvant chemotherapy
Locoregional Therapy
Participants undergo transoral robotic surgery or risk/response stratified chemoradiotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Toripalimab
Trial Overview
The study is testing how well Toripalimab works when combined with standard chemotherapy drugs Carboplatin and Paclitaxel in patients with advanced HPV-positive oropharyngeal cancer. It's a phase 2 trial that will also consider subsequent surgery or adjusted radiotherapy based on response to treatment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive toripalimab with neoadjuvant chemotherapy. After completion of the study treatment all patients will proceed with risk and response stratified locoregional therapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor
Citations
Efficacy and safety of toripalimab in the treatment ... - PMC - NIH
According to the Chinese Tumor Registry, the five-year survival rate of patients with nasopharyngeal cancer is approximately 60% to 70%; however ...
2.
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 ...
Toripalimab plus chemotherapy significantly extends overall survival in recurrent/metastatic NPC, with a 31-month improvement over chemotherapy ...
3.
investors.coherus.com
investors.coherus.com/news-releases/news-release-details/coherus-announces-positive-final-overall-survival-resultsCoherus Announces Positive Final Overall Survival Results ...
Toripalimab plus chemotherapy resulted in a 37% reduction in the risk of death, HR=0.63, versus chemotherapy alone, in nasopharyngeal carcinoma patients.
Updated results of adjuvant toripalimab for locally ...
The preliminary results highlighted that adjuvant toripalimab for LA-HNSCC patients who achieved pCR after NICT and surgery showed encouraging efficacy and ...
5.
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 ...
Toripalimab Plus Chemotherapy for Recurrent or ...
The study results showed that the addition of toripalimab to the standard platinum doublet chemotherapy resulted in significantly better ...
7.
cancernetwork.com
cancernetwork.com/view/expert-discusses-safety-of-toripalimab-in-advanced-nasopharyngeal-carcinomaExpert Discusses Safety of Toripalimab in Advanced ...
According to findings published in JAMA, 11.6% of patients who received toripalimab and 4.9% of those who were treated with placebo discontinued ...
Toripalimab in Combination With Standard Treatment for ...
This is a single-center phase 2 study of to test how well the combination of toripalimab with chemotherapy followed by TORS or risk and response stratified ...
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