Your session is about to expire
← Back to Search
Antimetabolite Chemotherapy
Chemotherapy + Surgery/Radiation for Head and Neck Cancer (OPTIMA-II Trial)
Phase 2
Waitlist Available
Led By Tanguy Seiwert, 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
Normal Organ Function: Leukocytes ≥3000/mm3, platelets ≥100,000/mm3, absolute neutrophil count ≥1,500, hemoglobin >9.0 gm/dL, AST and ALT <2.5 X ULN, alkaline phosphatase <2.5 X ULN, albumin >2.9 gm/dL, total bilirubin ≤1.5 mg/dl, creatinine clearance >45 mL/min (or SCr <1.5 mg/dL), normal within 2 weeks prior to start of treatment. The standard Cockcroft and Gault formula or the measured glomerular filtration rate must be used to calculate CrCl for enrollment or dosing.
Patients with AJCC (7th edition, 2010) N2-N3 nodal disease or T3-T4 primary tumor.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
OPTIMA-II Trial Summary
This trial will give carboplatin, nab-paclitaxel, and nivolumab to patients for three cycles of three weeks each. If the tumor responds well, the patient will either have surgery to remove the tumor or radiation therapy. If the tumor does not respond well, the patient will just have radiation therapy. All patients will also receive nivolumab for six months after treatment.
Who is the study for?
This trial is for adults with HPV-positive head and neck squamous cell carcinoma, who haven't had chemotherapy or radiation for it. They must have measurable disease by RECIST criteria, good organ function, no distant metastases, not be pregnant or nursing, and can't have received other recent cancer treatments or live vaccines.Check my eligibility
What is being tested?
The trial tests a combination of Carboplatin, nab-paclitaxel, and nivolumab chemotherapy followed by either Transoral robotic surgery (TORS) or Radiation/Chemoradiotherapy depending on the tumor's response. Post-treatment includes adjuvant nivolumab therapy for six months.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medications used in the study; nerve damage; immune system complications that could worsen existing conditions; fatigue from anemia; liver enzyme changes; potential heart issues due to strain from treatment.
OPTIMA-II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood tests show normal organ function.
Select...
My cancer has spread to nearby lymph nodes or is a large tumor.
Select...
I have not had radiation or chemotherapy for head or neck cancer.
Select...
I am fully active or have minor restrictions in physical activity.
Select...
I am 18 years old or older.
Select...
My cancer's HPV status will guide my treatment plan.
OPTIMA-II Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate the tumor shrinkage (%) to measure the deep response rate (DRR)
Secondary outcome measures
number of patients with adverse events
to measure the 2 year overall survival (OS)
to measure the 2 year progression-free survival (PFS)
+1 moreOPTIMA-II Trial Design
4Treatment groups
Experimental Treatment
Group I: Single Modality De-escalation Arm (SDA)Experimental Treatment3 Interventions
Following the induction treatments (carboplatin, nab-paclitaxel, and nivolumab), patients will be assessed based on response to chemotherapy and high or low risk status.
Patients with low risk and small volume tonsillar disease (T1-T2, non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) or base of tongue disease (T1-2 with lateralized primary ≤3 cm, non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) who have ≥50% reduction by RECIST following induction chemotherapy will undergo TORS and selective nodal dissection. De-intensified adjuvant RT will be given for adverse pathologic features. Patients may refuse TORS treatment.
Patients with low risk, who do not qualify for TORS (due to volume of disease or poor visualization/access) or refuse TORS, who have ≥50% reduction by RECIST following induction chemotherapy will be given de-intensified treatment with radiation alone to 50 G.
Group II: Regular Dose Arm (RDA)Experimental Treatment9 Interventions
Following the induction treatments (carboplatin, nab-paclitaxel, and nivolumab), patients will be assessed based on response to chemotherapy and high or low risk status.
Patients who have low risk disease and <30% reduction of tumor by RECIST with induction chemotherapy will receive CRT to 70 Gy with concurrent bolus cisplatin (x3 doses) or TFHX (paclitaxel, 5-FU, hydroxyurea, dexamethasone, famotidine, and diphenhydramine) to 75 Gy (5 cycles).
Patients who have high risk disease and <50% reduction of tumor by RECIST with induction chemotherapy will receive CRT to 70 Gy with concurrent bolus cisplatin (x3 doses) or TFHX to 75 Gy (5 cycles).
Any patient who has progressive disease will receive CRT to 70 Gy with concurrent bolus cisplatin (x3 doses) or TFHX to 75 Gy (5 cycles).
Group III: Intermediate De-escalation Arm (IDA)Experimental Treatment9 Interventions
Following the induction treatments (carboplatin, nab-paclitaxel, and nivolumab), patients will be assessed based on response to chemotherapy and high or low risk status.
Patients who have low risk disease with <50% but ≥30% reduction of tumor by RECIST with induction chemotherapy will receive CRT to 50 Gy with concurrent bolus cisplatin (x2 doses) or TFHX (paclitaxel, 5-FU, hydroxyurea, dexamethasone, famotidine, and diphenhydramine) to 45 Gy (3 cycles).
Patients who have high risk disease and ≥50% reduction of tumor by RECIST with induction chemotherapy will receive CRT to 50 Gy with concurrent bolus cisplatin (x2 doses) or TFHX to 45 Gy (3 cycles).
Group IV: Induction ChemotherapyExperimental Treatment3 Interventions
All enrolled patients will receive three 21-day cycles of chemotherapy consisting of nab-paclitaxel (100 mg/m2 on days 1, 8, 15; 9 doses total), carboplatin (AUC 5 on day 1; 3 doses total), and nivolumab (360 mg on days 1; 3 doses total). Growth factor support will be provided using G-CSF administered on days 16-18.
Adjuvant nivolumab will be offered to all patients for 6-months post completion of locoregional therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Famotidine
2005
Completed Phase 4
~1700
Diphenhydramine
2002
Completed Phase 4
~1170
Paclitaxel
2011
Completed Phase 4
~5380
Transoral robotic surgery (TORS)
2009
N/A
~160
Chemoradiotherapy
2010
Completed Phase 3
~350
nab-paclitaxel
2008
Completed Phase 4
~1330
Carboplatin
2014
Completed Phase 3
~6670
Nivolumab
2014
Completed Phase 3
~4750
Cisplatin
2013
Completed Phase 3
~1940
Hydroxyurea
2006
Completed Phase 4
~3620
5-FU
2014
Completed Phase 3
~3420
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,002 Previous Clinical Trials
817,774 Total Patients Enrolled
Tanguy Seiwert, MDPrincipal InvestigatorUniversity of Chicago
3 Previous Clinical Trials
26 Total Patients Enrolled
Everett Vokes, MDPrincipal InvestigatorUniversity of Chicago
7 Previous Clinical Trials
275 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to sign the consent form for this study.I have an active tuberculosis infection.I've had surgery for my cancer that wasn't just a biopsy or to reduce tumor size.I have not had cancer treatment in the last 8 weeks.My cancer is HPV-positive and located in my head, neck, or oropharynx.You are currently taking experimental medications that are not yet approved.I have not taken high doses of steroids or immunosuppressants in the last 7 days.I do not have any major health issues that would affect my treatment.I can provide at least 10 slides for testing or am willing to undergo a new biopsy.My blood tests show normal organ function.My cancer has spread to nearby lymph nodes or is a large tumor.I have not had radiation or chemotherapy for head or neck cancer.I haven't had complete surgery for head/neck cancer in the last 8 weeks.I am fully active or have minor restrictions in physical activity.I have been diagnosed with HIV.You are allergic to nivolumab or any other medicine used in this study.I am 18 years old or older.The origin of my cancer is unknown.My cancer has spread to distant parts of my body.My nerve damage does not severely affect my daily activities.I have another cancer, but it's not getting worse or needing treatment, except for certain skin cancers or early cervical cancer.I have an autoimmune disease but haven't needed strong medication for it in the last year.I have a history of or currently have non-infectious lung inflammation.I have active Hepatitis B or C, or had it but it's now eradicated.I have not received a live vaccine in the last 28 days.My cancer's HPV status will guide my treatment plan.
Research Study Groups:
This trial has the following groups:- Group 1: Single Modality De-escalation Arm (SDA)
- Group 2: Regular Dose Arm (RDA)
- Group 3: Induction Chemotherapy
- Group 4: Intermediate De-escalation Arm (IDA)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people will be a part of this clinical trial?
"This study isn't looking for any more participants. The trial was first posted on June 27th, 2017 and last updated on November 12th, 2021. If you're looking for other trials, there are currently 678 studies actively enrolling patients with carcinoma and 3082 trials for chemoradiotherapy that need participants."
Answered by AI
Are there any unfilled vacancies for volunteers in this experiment?
"This particular trial, which was initially posted on June 27th 2017 but edited most recently on November 12th 2021, is not actively recruiting patients. Although this specific study may be completed, there are still 3760 other clinical trials that need participants."
Answered by AI
Chemoradiotherapy is often used to treat what type of cancer?
"Chemoradiotherapy is an effective treatment for synovitis, a Helicobacter pylori infection, and metastatic bladder cancer."
Answered by AI
Has Chemoradiotherapy undergone extensive safety testing by the FDA?
"Chemoradiotherapy received a safety score of 2. This is due to the fact that, while there is some evidence supporting its safety, there are no studies affirming its efficacy."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger