Overview

Nivolumab Plus Pemetrexed for Head and Neck Squamous Cell Carcinoma

Status:
Recruiting
Trial end date:
2022-05-30
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to find out what effects the combination of Nivolumab and Pemetrexed has on you and your cancer. The safety of this combination and the effectiveness of this treatment will be studied.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AHS Cancer Control Alberta
Collaborator:
Alberta Cancer Foundation
Treatments:
Nivolumab
Pemetrexed
Criteria
Inclusion Criteria:

1. Patients must be 18 years of age or older.

2. Patients must have a diagnosis of histologically confirmed squamous cell carcinoma of
the head and neck not amenable to curative intent therapy (surgery or radical
chemoradiation).

3. Patients with squamous cell cancer of the head and neck (SCCHN) who either have a
recurrence within 6 months of potentially curative neoadjuvant/adjuvant platinum-based
therapy or recurrence after receiving plantium based therapy in a non-curative
setting, and who have a good performance status. Nivolumab may also be considered for
patients who are ineligible for a platinum-based chemotherapy.

4. Patients presenting with a diagnosis of HPV-related (p16+) squamous cell carcinoma
without an unknown primary will be eligible for enrolment if the investigator deems a
head and neck primary to be the most likely primary source.

5. Patients must be capable of providing consent to enrolment and treatment.

6. Patients with a performance status of ECOG 0-2(15) will be eligible for enrolment (see
appendix 1).

7. Measurable disease must be present according to RECIST criteria V1.1(16) (see appendix
5).

8. Women of child bearing potential (WOCBP) must have a negative serum (or urine)
pregnancy test at the time of screening. WOCBP is defined as any female who has
experienced menarche and who has not undergone surgical sterilization (hysterectomy or
bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal.
Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the
absence of other biological or physiological causes.

9. Patients (men and women) of childbearing / reproductive potential should use highly
effective birth control methods, as defined by the investigator, during the study
treatment period and for a period of 6 months after the last dose of study drug. A
highly effective method of birth control is defined as those that result in low
failure rate (i.e. less than 1% per year) when used consistently and correctly.

- Note: abstinence is acceptable if this is established and preferred contraception
for the patient and is accepted as a local standard.

10. Female patients who are breast-feeding should discontinue nursing prior to the first
dose of study treatment and until 30 days after the last dose of study drug.

11. Male patients should agree to not donate sperm during the study and for a period of at
least 6 months after last dose of study drug.

12. Absence of any condition hampering compliance with the study protocol and follow- up
schedule; those conditions should be discussed with the patient before registration in
the trial.

13. The following adequate organ function laboratory values must be met:

Hematological:

- Absolute neutrophil count (ANC) >1.5 x109/L

- Platelet count >100 x109/L

- Hemoglobin >9 g/dL (may have been transfused)

Renal:

-Estimated creatinine clearance ≥ 45 mL/min according to the Cockcroft-Gault formula (or
l-ocal institutional standard method)

Hepatic:

- Total serum bilirubin <1.5x ULN

- AST and ALT <2.5x ULN (or ≤ 5 x ULN for patients with documented metastatic disease to
the liver)

Exclusion Criteria:

1. History of pneumonitis requiring treatment with steroids.

2. History of active interstitial lung disease.

3. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular
accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months
prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart
Association Classification Class II), or serious cardiac arrhythmia requiring
medication.

4. History of another malignancy or a concurrent malignancy;

-Exceptions include patients who have been disease-free for 3 years, or patients with
a history of completely resected non-melanoma skin cancer or successfully treated in
situ carcinoma are eligible, for example cervical cancer in situ.

5. Active brain metastases or leptomeningeal disease.

-Patients with treated brain metastases that are stable for 6 weeks will be eligible
for enrolment.

6. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal,
inhaled, topical steroids, or local steroid injection (e.g., intra-articular
injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone
or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT
scan premedication).

7. Prior organ transplantation including allogeneic stem-cell transplantation.

8. Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory
agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid
diseases not requiring immunosuppressive treatment are eligible.

9. Active infection requiring systemic therapy.

10. Known prior severe hypersensitivity to investigational product or any component in its
formulations, including known severe hypersensitivity reactions to monoclonal
antibodies (CTCAE v4.03 Grade ≥ 3).

11. Other severe acute or chronic medical conditions including inflammatory bowel disease,
immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent
(within the past year) or active suicidal ideation or behavior; or laboratory
abnormalities that may increase the risk associated with study participation or study
treatment administration or may interfere with the interpretation of study results
and, in the judgment of the investigator, would make the patient inappropriate for
entry into this study.

12. Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 grade > 1); however,
alopecia, sensory neuropathy ≤ grade 2, or other toxicities ≤ grade 2 not constituting
a safety risk based on investigator's judgment are acceptable.