CTRI/2024/01/061661Not yet recruitingPhase 3
A Phase III ,Randomized controlled study comparing triple oral metronomic chemotherapy with low dose immunotherapy to intravenous chemotherapy in patients with advanced platinum sensitive head and neck squamous cell carcinoma in first line palliative setting. - NSCLC TMCI chemo
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Tata Memorial Centre
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1 Subjects must have head and neck squamous cell carcinoma and must be planned
- •for palliative systemic therapy in the first line.
- •2 Patients who have received prior platinum chemotherapy in the definitive setting will be eligible as long as the disease has relapsed 6 months or beyond the time that they had received platinum therapy.
- •Age more than 18 years.
- •Eastern Cooperative Oncology Group ECOG performance status PS 0 2
- •3 Subjects must have normal organ and marrow function
- •4 Patients with HIV are potentially eligible as long as they have a CD4 count more than and equal to 200 are on concurrent HAART highly active antiretroviral therapy, and absence of active AIDS defining conditions.
- •5 Pregnancy test Negative serum or urine pregnancy test at screening for women of
- •childbearing potential.
- •6 Contraception Highly effective contraception for both male and female subjects throughout
- •the study and for at least 30 days after last nivolumab treatment administration if the risk of
- •conception exists. Nivolumab is teratogenic to the developing human fetus.Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician immediately.
- •Willing and able to comply with all study requirements, including treatment, able to be
- •followed up at regular intervals and or nature of required assessments.
- •7Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- •1. Subjects who are receiving any other current investigational agents.
- •2. IMMUNOSUPPRESSANTS Current use of immunosuppressive medication EXCEPT for the
- •a. intranasal, inhaled, topical steroids, or local steroid injection
- •b. Systemic corticosteroids at physiologic doses more than and equal to 10 mg per day of prednisone or equivalent
- •c. Steroids as premedication for hypersensitivity reactions
- •d. Steroids for raised intracranial pressure due to the disease itself e, Steroid use
- •for avoidance or treatment of emesis.
- •3. AUTOIMMUNE DISEASE Active autoimmune disease that might deteriorate when receiving
- •a chemotherapeutic agent. Patients with diabetes type I vitiligo psoriasis or hypo or
- •hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
- •4. ORGAN TRANSPLANTATION Prior organ transplantation including allogeneic stem cell
- •transplantation.
- •5. INFECTIONS Active uncontrolled infection requiring systemic therapy.
- •6. VACCINATION Vaccination with live viral vaccine within 4 weeks of the first dose of nivolumab and while on studyis prohibited except for administration of inactivated vaccines.
- •7. HYPERSENSITIVITY TO STUDY DRUG Known prior severe hypersensitivity to
- •platinum, paclitaxel, oral metronomic chemotherapy, or nivolumab or any component in their formulations, including known severehypersensitivity reactions to monoclonal antibodies
- •8. CARDIOVASCULAR DISEASE: Clinically significant cardiovascular disease
- •cerebrovascular accident or stroke less than 6 months prior to enrollment myocardial infarction less than 6 months prior to enrollment, unstable angina, congestive heart failure, or serious cardiac arrhythmia requiring medication.
- •9. OTHER PERSISTING TOXICITIES Persisting toxicity related to prior therapy; however, alopecia, sensory neuropathy Grade 2, or other Grade 2 not
- •constituting a safety risk based on Investigator’s judgment is acceptable.
- •10. Other severe acute or chronic medical conditions including immune colitis, inflammatory
- •bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including
- •recent 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.
- •11. Pregnant women are excluded from this study. Based on its mechanism of action.
- •nivolumab can cause foetal harm when administered to a pregnant woman. Therefore,
- •potential risks of administering nivolumab during pregnancy include increased rates of abortion
- •or stillbirth. Women of reproductive potential will be advised to use effective contraception during treatment and for at least one month after the last dose of nivolumab.
- •12. Lactating women There is no information regarding the presence of nivolumab in human
- •milk, the effects on the breastfed infant, or the effects on milk production. Since many drugs are
- •excreted in human milk, it is advised that a lactating woman should not breastfeed during
- •treatment and for at least one month after the last dose of nivolumab due to the potential for
- •serious adverse
Investigators
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