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Tislelizumab + Pamiparib + Chemoradiation for Head and Neck Cancer

Phase 1
Recruiting
Led By Ari Rosenberg, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights

Study Summary

This trial is looking at the safety and tolerability of tislelizumab in combination with pamiparib and chemoradiotherapy for recurrent head and neck cancer. Participants will receive tislelizumab and chemoradiotherapy with pamiparib for about 15 months, followed by follow-up visits every 4 to 6 months for 4 years and then yearly for the rest of their life.

Who is the study for?
This trial is for adults with recurrent head and neck cancer who've had prior treatments. They must be in good physical condition, not pregnant or breastfeeding, willing to use contraception if necessary, and have no active autoimmune diseases or infections like HIV/Hepatitis B/C. Patients with certain high-risk features after surgery may also join.Check my eligibility
What is being tested?
The study tests the safety and best dose of tislelizumab (an immune therapy) combined with pamiparib (a targeted drug) plus standard chemoradiotherapy in patients whose head and neck cancer has returned. Participants will receive treatment for about 15 months followed by regular clinic visits for up to life-long monitoring.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells, fatigue, digestive issues from chemotherapy, skin changes due to radiation, blood-related problems such as anemia or clotting issues, and increased risk of infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose/Recommended Phase 2 Dose of Pamiparib in Combination with 5 Fluorouracil-Hydroxea (FHX) and Tislelizumab
Secondary outcome measures
Overall Free Survival of Participants Receiving Pamiparib in Combination with 5 Fluorouracil-Hydroxea (FHX) and Tislelizumab
Progression Free Survival of Participants Receiving Pamiparib in Combination with 5 Fluorouracil-Hydroxea (FHX) and Tislelizumab

Side effects data

From 2013 Phase 3 trial • 688 Patients • NCT00424255
63%
Mucosal inflammation
52%
Nausea
48%
Rash
44%
Vomiting
42%
Diarrhoea
42%
Dry mouth
36%
Dysphagia
26%
Weight decreased
25%
Lymphopenia
24%
Leukopenia
22%
Anaemia
20%
Neutropenia
18%
Pyrexia
18%
Decreased appetite
17%
Constipation
17%
Asthenia
16%
Radiation skin injury
14%
Stomatitis
13%
Cough
13%
Oropharyngeal pain
13%
Blood creatinine increased
12%
Odynophagia
12%
Skin reaction
12%
Fatigue
12%
Hypokalaemia
9%
White blood cell count decreased
9%
Haemoglobin decreased
9%
Hyponatraemia
9%
Dysgeusia
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
9%
Dyspepsia
8%
Creatinine renal clearance decreased
7%
Dysphonia
7%
Pruritus
7%
Productive cough
7%
Oral pain
7%
Thrombocytopenia
6%
Lymphocyte count decreased
6%
Headache
6%
Neck pain
5%
Oral candidiasis
5%
Insomnia
4%
Radiation mucositis
4%
Musculoskeletal pain
3%
Ejection fraction decreased
2%
Pneumonia
2%
Dehydration
1%
Hepatic enzyme increased
1%
Oesophageal stenosis
1%
Pharyngeal fistula
1%
Epistaxis
1%
Hyperkalaemia
1%
Acute respiratory failure
1%
Mouth haemorrhage
1%
Wound infection
1%
Febrile neutropenia
1%
General physical health deterioration
1%
Hyperuricaemia
1%
Malnutrition
1%
Hypocalcaemia
1%
Feeding disorder
1%
Sepsis
1%
Lung abscess
1%
Oral infection
1%
Blood uric acid increased
1%
Dyspnoea
1%
Pneumonia aspiration
1%
Tracheostomy malfunction
1%
Cerebral ischaemia
1%
Renal failure
1%
Renal impairment
1%
Hyperbilirubinaemia
1%
Depression
1%
Death
1%
Left ventricular dysfunction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Lapatinib 1500 mg

Trial Design

4Treatment groups
Experimental Treatment
Group I: Dose-Finding Group 3: Dose Level 3 (Part 1 of Study)Experimental Treatment5 Interventions
The purpose of part 1 is to determine the best tolerated dose of study drugs with the least side effects. Dose escalation means that some participants will receive a different (higher) dose than other participants depending on when they join the study. This is to determine side effects at different doses and find a dose that will be safe to give to all participants. Participants in this group will receive: One dose of tislelizumab (200 mg) 15 days before chemoradiotherapy (CRT) given intravenously (by IV), which means through a vein. Chemoradiotherapy over a period of 5 weeks. During each cycle of CRT, participants will receive: Pamiparib (40 mg twice daily on days 0-5 of each 14 -day cycle) along with 5FU and hydroxyurea for 5 days. Radiation will also be given two times a day for 5 days After CRT, participants will rest for roughly 8 days without study drugs or radiation then they will receive tislelizumab (200 mg) for 12 months by IV over 30 minutes every 6 weeks.
Group II: Dose-Finding Group 2: Dose Level 2 (Part 1 of Study)Experimental Treatment5 Interventions
The purpose of part 1 is to determine the best tolerated dose of study drugs with the least side effects. Dose escalation means that some participants will receive a different (higher) dose than other participants depending on when they join the study. This is to determine side effects at different doses and find a dose that will be safe to give to all participants. Participants in this group will receive: One dose of tislelizumab (200 mg) 15 days before chemoradiotherapy (CRT) given intravenously (by IV), which means through a vein. Chemoradiotherapy over a period of 5 weeks. During each cycle of CRT, participants will receive: Pamiparib (20 mg twice daily on days 0-5 of each 14 -day cycle) along with 5FU and hydroxyurea for 5 days. Radiation will also be given two times a day for 5 days After CRT, participants will rest for roughly 8 days without study drugs or radiation then they will receive tislelizumab (200 mg) for 12 months by IV over 30 minutes every 6 weeks.
Group III: Dose-Finding Group 1: Dose Level 1 (Part 1 of Study)Experimental Treatment5 Interventions
The purpose of part 1 is to determine the best tolerated dose of study drugs with the least side effects. Dose escalation means that some participants will receive a different (higher) dose than other participants depending on when they join the study. This is to determine side effects at different doses and find a dose that will be safe to give to all participants. Participants in this group will receive: One dose of tislelizumab (200 mg) 15 days before chemoradiotherapy (CRT) given intravenously (by IV), which means through a vein. Chemoradiotherapy over a period of 5 weeks. During each cycle of CRT, participants will receive: Pamiparib (20 mg daily on days 0-5 of each cycle) along with 5FU and hydroxyurea for 5 days. Radiation will also be given two times a day for 5 days After CRT, participants will rest for roughly 8 days without study drugs or radiation then they will receive tislelizumab (200 mg) for 12 months by IV over 30 minutes every 6 weeks.
Group IV: Dose Expansion Group ( Part II of Study)Experimental Treatment5 Interventions
Part 2 (dose expansion phase): The purpose of this part is to continue to evaluate the dose of study drugs that is the best tolerated and has the least side effects. This part will start once the dose is selected from part 1. Enrollment in this part of the study is dependent on when participants join the study. Approximately 18 subjects will be enrolled in Part 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemoradiation
2006
Completed Phase 3
~990
Pamiparib
2017
Completed Phase 2
~750
Hydroxyurea
2006
Completed Phase 4
~3620
Tislelizumab
2018
Completed Phase 3
~4260

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,747 Total Patients Enrolled
Ari Rosenberg, MDPrincipal InvestigatorUniversity of Chicago
4 Previous Clinical Trials
584 Total Patients Enrolled

Media Library

Chemoradiation Clinical Trial Eligibility Overview. Trial Name: NCT05526924 — Phase 1
Head and Neck Cancers Research Study Groups: Dose-Finding Group 1: Dose Level 1 (Part 1 of Study), Dose-Finding Group 2: Dose Level 2 (Part 1 of Study), Dose-Finding Group 3: Dose Level 3 (Part 1 of Study), Dose Expansion Group ( Part II of Study)
Head and Neck Cancers Clinical Trial 2023: Chemoradiation Highlights & Side Effects. Trial Name: NCT05526924 — Phase 1
Chemoradiation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05526924 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still seeking participants for this investigation?

"Per the clinicaltrials.gov listing, this trial is no longer accepting candidates. Initially posted on November 1st 2022, it was last updated on August 31st 2022. While this particular study has concluded recruitment, there are 3010 alternate trials actively seeking patients at present."

Answered by AI

Has the application of Chemoradiation been approved by the Food and Drug Administration?

"Chemoradiation's safety profile has been assessed at a level 1 due to the limited clinical research in both efficacy and toxicity."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer
2023. "Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05526924.
~18 spots leftby Jan 2026
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