Clinical trial for Head and Neck Cancer
Official title Concurrent Immunotherapy and Systemic Therapy With Stereotactic Body Radiation Therapy (SBRT) for Stage IV Cancers (COINSSS IV)
ClinicalTrials.gov ID: NCT07770100
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, being studied as a potential treatment for head and neck cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase II clinical study for people with stage IV cancer.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Histologically proven advanced or stage IV head \& neck, non-small cell lung cancer, cervical, esophageal, gastric, and gastroesophageal cancer at...
- At least 6 metastases eligible for SBRT comprising: lung, liver, adrenal glands, bone, and lymph node sites
- The 1 irradiated lesion must have a max point dose of 5Gy or less.
- Eligible for Immunotherapy for an FDA-approved indication as defined in section 6.1.
- If prior treatment with chemotherapy or radiotherapy or surgery has occurred: Prior chemotherapy or radiation must have concluded \> 21 days prior to...
You likely can't join if
- Presence of \< or equal to 5 sites amenable to SBRT
- Ineligible for immune checkpoint inhibitors based on package insert of the chosen immune checkpoint inhibitor
- No more than 7 metastatic sites to an organ, defined as liver, left lung, right lung, single anatomically bone site (e.g.
- Peritoneal involvement, at the discretion of the study PI. NOTE: Peritoneal metastasis does not exclude GI nor cervical cancer, except in cases where...
- Presence of liver cirrhosis of any grade prohibits SBRT to the liver.
- A plan that cannot meet organ at risk tolerance (as defined in section 6.7.2.1) Auto-immune diagnosis Medications prohibited while receiving...
See the full eligibility criteria
Who can join
- Histologically proven advanced or stage IV head \& neck, non-small cell lung cancer, cervical, esophageal, gastric, and gastroesophageal cancer at least 6 metastases that are eligible for SBRT comprising: lung, liver...
- At least 6 metastases eligible for SBRT comprising: lung, liver, adrenal glands, bone, and lymph node sites
- The 1 irradiated lesion must have a max point dose of 5Gy or less.
- Eligible for Immunotherapy for an FDA-approved indication as defined in section 6.1. NOTE: No limit is placed on prior systemic treatment unless it affects the eligibility for administration of immune checkpoint...
- If prior treatment with chemotherapy or radiotherapy or surgery has occurred: Prior chemotherapy or radiation must have concluded \> 21 days prior to the start of study treatment.
- First Line immunotherapy-based treatments only. The patient may have received prior cycles of immunotherapy, but has to be on the first line of immunotherapy-based treatments.
- If non-small cell lung cancer patient with pembrolizumab, PD-L1 testing CPS score \> or = to 50% will have to be shown
- If cervical cancer patient on secondary line therapy with pembrolizumab, CPS score of \> or = to 1 will have to be done.
- If non-small cell lung cancer on first line ipilimumab in combination with nivolumab, PD-L1 of 1% and negative epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
- If pembrolizumab is given for a gastric cancer, a PD-L1 expression (CPS =1) will need to be shown
- If pembrolizumab is given as a single agent treatment after progression of one prior systemic therapy agent for esophageal or gastroesophageal squamous cell carcinoma histology, a PD-L1 (CPS=1) expression will have to...
- ECOG Performance Status 0 - 1 (see Appendix A).
- Life expectancy \> or equal to 6 months.
- Adequate organ and bone marrow function prior to study treatment as defined by: Thresholds for lab values prior to initiation of study treatment.
- ANC \> or equal to 1,000/mm3
- Platelets \> or equal to 100,000/mm3
- Total bilirubin \< or equal to or equal to 1.5 x ULN
- AST and ALT - With hepatic metastasis, \< or equal to or equal to 5 x ULN. If no hepatic metastasis, \< or equal to 2.5 times x ULN
- Creatinine Or Creatinine Clearance \ or equal to 30ml/min (per 24-hour urine collection) or calculated according to the Cockcroft-Gault formula (Appendix B)
- No previous or concurrent malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for the past 3...
- Non-pregnant and non-nursing women -Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.
- Women of childbearing potential and men must agree to use adequate contraception methods prescribed their the patients primary care physician, urologist, or obstetrician/gynecologist prior to study entry and for the...
- people should use adequate birth control for at least 3 months after the last administration of immune checkpoint inhibitors.
- Ability to understand and the willingness to sign a written informed consent document
What rules you out
- Presence of \< or equal to 5 sites amenable to SBRT
- Ineligible for immune checkpoint inhibitors based on package insert of the chosen immune checkpoint inhibitor
- No more than 7 metastatic sites to an organ, defined as liver, left lung, right lung, single anatomically bone site (e.g. femur, humerus, single vertebral body). NOTE: Multiple different vertebral bodies are allowed.
- Peritoneal involvement, at the discretion of the study PI. NOTE: Peritoneal metastasis does not exclude GI nor cervical cancer, except in cases where there is a separate focus of spread to the peritoneum.
- Presence of liver cirrhosis of any grade prohibits SBRT to the liver. NOTE: Pt can enroll to trial if receiving SBRT to other non-liver metastatic sites.
- A plan that cannot meet organ at risk tolerance (as defined in section 6.7.2.1) Auto-immune diagnosis Medications prohibited while receiving concurrent SBRT: gemcitabine, Adriamycin, VEGF or BRAF inhibitors.
- Active clinically serious infection \> CTCAE Grade 2.
- Serious non-healing wound, ulcer or bone fracture.
- Uncontrolled inter-current illness. This includes, but is not limited to: ongoing or active infection; symptomatic congestive heart failure (NYHA class III or IV); unstable angina pectoris or new onset angina that began...
- Uncontrolled hypertension defined as systolic blood pressure \>150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management; Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or...
- Receipt of live attenuated vaccine within 30 days prior to the first dose of ICI. Note: Patients, if assigned by chance, should not receive live vaccine while receiving ICI and up to 30 days after the last dose of ICI.
The study team makes the final eligibility decision.
Where it is enrolling
- Lexington, Kentucky, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Lexington, Kentucky, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.