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Monoclonal Antibodies
Ramucirumab + Pembrolizumab for Head and Neck Cancer
Phase 1 & 2
Waitlist Available
Led By Douglas R Adkins, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate blood and organ function as defined: Absolute neutrophil count ≥ 1,500/mcL; Platelets ≥ 100,000/mcL; Hemoglobin ≥ 9.0 g/dL; Total bilirubin ≤ 1.5 mg/dL; AST(SGOT) ≤ 3 x institutional upper limit of normal (IULN) and ALT(SGPT) ≤ 3 x IULN. In the setting of liver metastases, AST < 5 x IULN and ALT < 5 x IULN; Creatinine ≤ 2 x ULN OR creatinine clearance ≥ 40 mL/min/1.73 m2; Urine protein to creatinine ratio (UPC) ≤ 1; INR ≤ 1.5 x ULN (≤ 3.0 x ULN if on anticoagulation) and PTT ≤ 1.5 x ULN (<3 x ULN if on anticoagulation); Women of childbearing potential and men must agree to use adequate contraception
Performance status 0-2 (ECOG)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of first cycle of treatment for all patients enrolled in phase i portion of study (estimated to be 2.5 months)
Awards & highlights
Study Summary
This trial is testing the combination of two drugs to see if they are more effective than one of the drugs alone in treating head and neck cancer. The first part of the trial establishes the safety of the combination and the second part looks at its efficacy.
Who is the study for?
This trial is for adults with incurable head and neck squamous cell carcinoma (HNSCC) that can't be treated by surgery or radiation, or if the patient declines such treatments. Participants need to have certain blood counts and organ functions within specific ranges, no severe allergies to study agents, no recent heart attacks or strokes, and must not be pregnant. They should agree to use contraception and have not received certain therapies recently.Check my eligibility
What is being tested?
The trial tests combining Ramucirumab with Pembrolizumab versus Pembrolizumab alone in treating HNSCC. Phase I determines the safe dose of Ramucirumab when combined with Pembrolizumab while phase II evaluates how effective this combination is as a first-line treatment by looking at tumor response rates.See study design
What are the potential side effects?
Potential side effects include allergic reactions related to the drugs used, increased risk of bleeding or clotting issues due to angiogenesis inhibition (Ramucirumab), immune system-related side effects like inflammation from PD-1 inhibition (Pembrolizumab), fatigue, digestive problems, and possibly others depending on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to get out of my bed or chair and move around.
Select...
My head or neck cancer cannot be cured with surgery or radiation, or I cannot undergo these treatments.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completion of first cycle of treatment for all patients enrolled in phase i portion of study (estimated to be 2.5 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of first cycle of treatment for all patients enrolled in phase i portion of study (estimated to be 2.5 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall tumor response rate of ramucirumab and pembrolizumab (Phase II patients only)
Recommended phase 2 dose (RP2D) of ramucirumab combined with fixed dose pembrolizumab (Phase I patients only)
Secondary outcome measures
Adverse event profile of the combination of ramucirumab and pembrolizumab (Phase I and II patients) as measured by the frequency of adverse events
Changes in quality of life as measured by EORTC QLQ-C30 (Phase II patients only)
Changes in quality of life as measured by FACT H&N (Phase II patients only)
+3 moreSide effects data
From 2016 Phase 3 trial • 1253 Patients • NCT0116897346%
Fatigue
36%
Neutropenia
32%
Diarrhoea
30%
Decreased appetite
27%
Nausea
26%
Alopecia
24%
Dyspnoea
23%
Stomatitis
22%
Cough
22%
Anaemia
19%
Epistaxis
18%
Neutrophil count decreased
17%
Oedema peripheral
17%
Constipation
16%
Mucosal inflammation
16%
Pyrexia
14%
Lacrimation increased
14%
Vomiting
14%
Febrile neutropenia
13%
Myalgia
13%
Leukopenia
12%
Peripheral sensory neuropathy
12%
Back pain
11%
Dysgeusia
11%
Hypertension
11%
Insomnia
11%
Headache
11%
Arthralgia
11%
Asthenia
11%
Weight decreased
9%
Abdominal pain
9%
White blood cell count decreased
8%
Oropharyngeal pain
8%
Pain in extremity
8%
Thrombocytopenia
7%
Rash
7%
Dizziness
7%
Nail discolouration
6%
Dehydration
6%
Pain
6%
Dyspepsia
6%
Haemoptysis
6%
Paraesthesia
6%
Dysphonia
6%
Productive cough
6%
Hyperglycaemia
6%
Pneumonia
6%
Platelet count decreased
5%
Bone pain
1%
Chronic obstructive pulmonary disease
1%
Hyponatraemia
1%
Metastatic pain
1%
Lobar pneumonia
1%
Pleural effusion
1%
Pneumothorax
1%
Pulmonary embolism
1%
Pulmonary haemorrhage
1%
Syncope
1%
Confusional state
1%
Death
1%
Atrial fibrillation
1%
General physical health deterioration
1%
Renal failure acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ramucirumab and Docetaxel
Placebo and Docetaxel
Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase II: Ramucirumab + PembrolizumabExperimental Treatment5 Interventions
-Patients will be treated with ramucirumab at the RP2D on Day 1 and SOC pembrolizumab (200 mg IV over 30 minutes) on Day 1 of each 21-day cycle.
Group II: Phase I: Ramucirumab + PembrolizumabExperimental Treatment3 Interventions
-Ramucirumab will be administered IV over 1 hour on Day 1 of each 21-day cycle. Pembrolizumab will be administered as per standard of care (IV at a dose of 200 mg over 30 minutes on Day 1 of each 21-day cycle). On Day 1, pembrolizumab will be given after ramucirumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peripheral blood
2018
Completed Phase 1
~70
Ramucirumab
2017
Completed Phase 3
~5050
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyIndustry Sponsor
2,615 Previous Clinical Trials
3,201,015 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,666 Total Patients Enrolled
Douglas R Adkins, M.D.Principal InvestigatorWashington University School of Medicine
6 Previous Clinical Trials
291 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had PD-1 inhibitor therapy for incurable head and neck cancer.I haven't had cancer treatment like radiation or chemotherapy in the last 14 days.I haven't had major surgery or significant bleeding from the tumor site in the last 14 days.I have not had a GI perforation or fistula in the last 6 months.My liver condition is severe, with complications like swelling or confusion.I haven't taken high-dose steroids or immunosuppressants in the last week.My blood pressure is not well controlled.I haven't had a blood clot in an artery in the last 3 months.My cancer is in my mouth, throat, voice box, nose, or salivary glands.I am able to get out of my bed or chair and move around.I have an autoimmune disease treated with injections in the last 6 months.I have a history of GI issues like Crohn's disease or ulcerative colitis.My head or neck cancer cannot be cured with surgery or radiation, or I cannot undergo these treatments.For Phase I, I've had treatments for RM-HNSCC. For Phase II, I haven't had systemic therapy for RM-HNSCC.I have side effects from cancer treatment that are mild, except for hair loss, tiredness, or skin issues.I have not had severe GI bleeding in the last 3 months.I am 18 years old or older.I am currently receiving radiation for brain metastases.I have had cancer other than skin cancer or low-risk types in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I: Ramucirumab + Pembrolizumab
- Group 2: Phase II: Ramucirumab + Pembrolizumab
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.
What medical ailments is Ramucirumab typically employed to address?
"Ramucirumab is widely used to treat malignant neoplasms and can also be beneficial for individuals with unresectable melanoma, microsatellite instability high, or chemotherapy-induced disease progression."
Answered by AI
To what extent has Ramucirumab been investigated in other research?
"As of now, there are over 1000 active clinical trials examining the potential efficacy of Ramucirumab. The vast majority (129) have reached Phase 3 and research is mainly conducted in Boston, Massachusetts - with 37993 locations operating related studies worldwide."
Answered by AI
How many participants are undergoing treatment in this clinical trial?
"At present, this trial is not accepting new patients. Initially posted on May 29th 2019 and last updated on August 8th of 2022, other studies are currently enrolling individuals with oral squamous cell carcinoma at a rate of 2676 trials and 1000 clinical trials using ramucirumab as the intervention."
Answered by AI
Are there any opportunities to join this investigation?
"The clinical trial listed on clinicialtrials.gov is currently not recruiting, having last been updated in August of 2022. Nevertheless, there are an abundance of other trials that need volunteers right now - with 3676 active studies accepting participants at this moment."
Answered by AI
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