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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
No Placebo-Only Group
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose/Recommended Phase 2 Dose of Pamiparib in Combination with 5 Fluorouracil-Hydroxea (FHX) and Tislelizumab
Secondary study objectives
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 • NCT0042425563%
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%
Oropharyngeal pain
13%
Cough
13%
Blood creatinine increased
12%
Skin reaction
12%
Odynophagia
12%
Fatigue
12%
Hypokalaemia
9%
Hyponatraemia
9%
White blood cell count decreased
9%
Dysgeusia
9%
Haemoglobin decreased
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
9%
Dyspepsia
8%
Creatinine renal clearance decreased
7%
Pruritus
7%
Dysphonia
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%
Epistaxis
1%
Hepatic enzyme increased
1%
Pharyngeal fistula
1%
Oesophageal stenosis
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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:
1. One dose of tislelizumab (200 mg) 15 days before chemoradiotherapy (CRT) given intravenously (by IV), which means through a vein.
2. 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
3. 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:
1. One dose of tislelizumab (200 mg) 15 days before chemoradiotherapy (CRT) given intravenously (by IV), which means through a vein.
2. 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
3. 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:
1. One dose of tislelizumab (200 mg) 15 days before chemoradiotherapy (CRT) given intravenously (by IV), which means through a vein.
2. 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
3. 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
Hydroxyurea
2006
Completed Phase 4
~3490
Tislelizumab
2018
Completed Phase 3
~4700
Pamiparib
2017
Completed Phase 2
~750
Chemoradiation
2006
Completed Phase 3
~990
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,056 Previous Clinical Trials
760,879 Total Patients Enrolled
Ari Rosenberg, MDPrincipal InvestigatorUniversity of Chicago
4 Previous Clinical Trials
584 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My throat cancer has been tested positive for HPV.I do not have active lung problems like fibrosis or uncontrolled lung disease.I have an active tuberculosis infection.I have cancer that has spread to my brain.I agree to use birth control during and for 6 months after treatment if I'm sexually active with women who can become pregnant.My head or neck cancer has come back and needs treatment.My gastrointestinal function is significantly affected by a disease or procedure.I am HIV-positive and on combination antiretroviral therapy.I haven't had chemotherapy in the last 4 weeks and have recovered from any side effects.I am fully active and can carry on all pre-disease activities without restriction.I am not taking any strong CYP3A inducer medications.I have an autoimmune disease treated with medication in the last year.I have active Hepatitis B or C.I have been treated before for my cancer that has not spread beyond its original region.I have another cancer that is getting worse or needs treatment.I have not received a live vaccine in the last 28 days.I finished my last cancer treatment over a month ago and have recovered from side effects.I am 18 years old or older.My organ and bone marrow functions are normal as per lab tests.I had surgery for cancer with high-risk features and am eligible for additional radiation.I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.My cancer in the head or neck area has returned but hasn't widely spread, or it's spread but can be treated with targeted radiation.I have had chemotherapy before.I have previously been treated with PD-1 or PD-L1 inhibitors.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Dose-Finding Group 1: Dose Level 1 (Part 1 of Study)
- Group 2: Dose-Finding Group 2: Dose Level 2 (Part 1 of Study)
- Group 3: Dose-Finding Group 3: Dose Level 3 (Part 1 of Study)
- Group 4: Dose Expansion Group ( Part II of Study)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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