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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.

Must not have

Has a known history of active tuberculosis (Bacillus Tuberculosis infection).

Prior surgical therapy other than incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors. Residual measurable tumor is required for enrollment on study as outlined above.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood tests show normal organ function.

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My cancer has spread to nearby lymph nodes or is a large tumor.

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I have not had radiation or chemotherapy for head or neck cancer.

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I am fully active or have minor restrictions in physical activity.

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I am 18 years old or older.

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My cancer's HPV status will guide my treatment plan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active tuberculosis infection.

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I've had surgery for my cancer that wasn't just a biopsy or to reduce tumor size.

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I have not had cancer treatment in the last 8 weeks.

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I have not taken high doses of steroids or immunosuppressants in the last 7 days.

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I do not have any major health issues that would affect my treatment.

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I have been diagnosed with HIV.

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The origin of my cancer is unknown.

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My cancer has spread to distant parts of my body.

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My nerve damage does not severely affect my daily activities.

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I have an autoimmune disease but haven't needed strong medication for it in the last year.

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I have a history of or currently have non-infectious lung inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate the tumor shrinkage (%) to measure the deep response rate (DRR)

Secondary study objectives

number of patients with adverse events

to measure the 2 year rates of locoregional and distant control

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: 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

Diphenhydramine

2002

Completed Phase 4

~1170

Paclitaxel

2011

Completed Phase 4

~5370