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Monoclonal Antibodies

Rucaparib + Ramucirumab +/- Nivolumab for Stomach and Esophageal Cancer (RiME Trial)

Phase 1 & 2

Waitlist Available

Led By Anwaar Saeed, MD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Absence of active autoimmune disease that has required systemic treatment in the past 2 years

Gastric or gastroesophageal junction adenocarcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

RiME Trial Summary

This trial is for people with advanced stomach, gastroesophageal, or esophageal cancer who have failed initial chemotherapy. The goal is to see if Rucaparib plus Ramucirumab with or without Nivolumab is more effective than what has been reported for Ramucirumab alone. The trial will have a phase 1 component to determine the recommended dosage, and a phase 2 component to compare the two treatment groups.

Who is the study for?

This trial is for adults with advanced gastric or esophageal adenocarcinoma who've had standard chemotherapy but the cancer has progressed. They must have a specific gene alteration, measurable disease, and good organ function. Those with autoimmune diseases, recent steroid treatment, or untreated brain metastases can't join.Check my eligibility

What is being tested?

The study tests Rucaparib plus Ramucirumab with or without Nivolumab in patients whose cancer didn't respond to initial treatments. It's a two-part trial: Phase 1 finds the best dose; Phase 2 compares how well each drug combination works.See study design

What are the potential side effects?

Possible side effects include fatigue, nausea, increased risk of infection due to immune system effects, high blood pressure from Ramucirumab and anemia from Rucaparib. Nivolumab may cause immune-related issues like inflammation in organs.

RiME Trial Eligibility Criteria

Inclusion Criteria

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

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I haven't needed treatment for an autoimmune disease in the last 2 years.

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My cancer is in the stomach or where the stomach meets the esophagus.

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My HER2 positive cancer has worsened despite previous HER2 targeted treatments.

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My cancer is at an advanced stage and cannot be surgically removed.

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I agree not to father a child or donate sperm during and for 7 months after the study.

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My condition worsened or I couldn't tolerate at least one standard treatment.

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I am post-menopausal or not pregnant if pre-menopausal.

RiME Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate (ORR)

Recommended Phase 2 Dose (RP2D)

Secondary outcome measures

Number of participants with treatment related adverse events (TRAEs)

Overall Benefit Rate (OBR)

Overall survival (OS)

+1 more

Side effects data

From 2022 Phase 3 trial • 564 Patients • NCT01968213

76%

Nausea

70%

Combined Asthenia/Fatigue

52%

Fatigue

39%

Combined Anaemia and/or decreased hemoglobin

38%

Constipation

38%

Vomiting

37%

Anaemia

35%

Diarrhoea

35%

Alanine aminotransferase increased

34%

Combined ALT/AST increased

33%

Abdominal pain

31%

Dysgeusia

29%

Combined Thrombocytopenia and/or decreased platelets

27%

Aspartate aminotransferase increased

25%

Decreased appetite

23%

Asthenia

22%

Arthralgia

20%

Headache

19%

Combined Neutropenia and/or decreased ANC

19%

Photosensitivity reaction

18%

Cough

17%

Thrombocytopenia

17%

Blood creatinine increased

16%

Dyspepsia

16%

Insomnia

16%

Dizziness

15%

Pruritus

15%

Rash

15%

Dyspnoea

15%

Abdominal pain upper

15%

Back pain

15%

Pyrexia

14%

Platelet count decreased

14%

Neutropenia

13%

Abdominal distension

13%

Upper respiratory tract infection

12%

Hypertension

12%

Oedema peripheral

12%

Hypomagnesaemia

10%

Nasopharyngitis

10%

Alopecia

10%

Taste disorder

10%

Dry skin

10%

Urinary tract infection

Mucosal inflammation

Influenza

Depression

Stomatitis

Erythema

Anxiety

Neutrophil count decreased

Hypercholesterolaemia

Dry mouth

Weight decreased

Myalgia

Oropharyngeal pain

White blood cell count decreased

Gastrooesophageal reflux disease

Influenza like illness

Hot flush

Neck pain

Pain in extremity

Blood alkaline phosphatase increased

Muscle spasms

Sinusitis

Combined Anemia and/or low hemoglobin

Incarcerated hernia

General physical health deterioration

Intestinal obstruction

Sepsis

Muscular weakness

Combined Thrombocytopenia and/or low platelets

Osteoarthritis

Gastrointestinal pain

Pulmonary embolism

Febrile neutropenia

Pancytopenia

Small intestinal obstruction

Dehydration

Combined Netropenia and/or low ANC

Malignant melanoma

Malignant neoplasm progression

Myelodysplastic syndrome

Seizure

Acute kidney injury

Renal failure

100%

80%

60%

40%

20%

Study treatment Arm

Rucaparib 600 mg Tablets

Placebo Tablets

RiME Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Safety Lead InExperimental Treatment3 Interventions

Rucaparib 600 milligrams twice daily Ramucirumab 8 milligrams per kilogram intravenous every 2 weeks Nivolumab 480 milligrams intravenous every 4 weeks Treatment will continue until disease progression, unacceptable toxicity or the patient desires to discontinue this therapy One dose level decrease of Rucaparib will be planned if toxicity develops in the first 6 patients 1 cycle= 28 days

Group II: Cohort AExperimental Treatment3 Interventions

Group III: Cohort BActive Control2 Interventions

Rucaparib 600 milligrams twice daily Ramucirumab 8 milligrams per kilogram intravenous every 2 weeks Treatment will continue until disease progression, unacceptable toxicity or the patient desires to discontinue this therapy 1 cycle= 28 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rucaparib

2016

Completed Phase 3

~1990

Ramucirumab

2017

Completed Phase 3

~5050

Nivolumab

2014

Completed Phase 3

~4750

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,480 Total Patients Enrolled

University of Kansas Medical CenterLead Sponsor

460 Previous Clinical Trials

169,081 Total Patients Enrolled

Clovis Oncology, Inc.Industry Sponsor

64 Previous Clinical Trials

11,637 Total Patients Enrolled

Media Library

Ramucirumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03995017 — Phase 1 & 2

Stomach Cancer Research Study Groups: Cohort B, Safety Lead In, Cohort A

Stomach Cancer Clinical Trial 2023: Ramucirumab Highlights & Side Effects. Trial Name: NCT03995017 — Phase 1 & 2

Ramucirumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03995017 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being accepted for enrollment in this experiment?

"Affirmative. According to the clinicaltrials.gov listing, this research trial is actively recruiting participants - it was initially published on 9th January 2020 and last updated 31st January 2022. The study requires 61 volunteers at 14 separate sites across the country/world."

Answered by AI

What medical conditions is Rucaparib commonly prescribed to address?

"Rucaparib is a widely used medication to treat malignant neoplasms, and it can also be beneficial in managing unresectable melanoma, squamous cell carcinomas, and metastatic esophageal adenocarcinoma."

Answered by AI

How many participants are currently enrolled in this research project?

"This medical study, sponsored by Bristol-Myers Squibb, necessitates the recruitment of 61 qualified participants. Truman Medical Center in Kansas City, Missouri and St Francis Comprehensive Cancer Centre in Topeka, Illinois are two of many locations that will be conducting this trial."

Answered by AI

What additional investigations have been conducted using Rucaparib?

"Back in 2012, the initial investigation into rucaparib first took place at Local Institution. This has since led to 327 completed studies with an additional 786 ongoing trials occurring across Kansas City, Missouri."

Answered by AI

Has there ever been a similar study conducted before?

"Since its inception in 2012, when it was initially developed by Ono Pharmaceutical Co. Ltd., Rucaparib has been extensively studied and is currently the subject of 786 active trials across 50 countries and 2460 cities. Following a successful Phase 1 & 2 trial involving 659 participants, the drug received approval for clinical use."

Answered by AI

How many venues can a participant access this clinical research at?

"Currently, 14 medical centres are operating for this research study. These include Truman Medical Center in Kansas City and St. Francis Comprehensive Cancer Centre in Topeka, among numerous other sites."

Answered by AI

What goals are investigators expecting to accomplish with this research?

"Per the sponsor, Bristol-Myers Squibb, this clinical trial's primary outcome will be Recommended Phase 2 Dose (RP2D), assessed over a 12 month period. Secondary objectives include determining Overall Benefit Rate (OBR) via modified RECIST version 1.1; Progression Free Survival (PFS); and Number of participants with treatment related adverse events (TRAEs). CTCAE 5.0 is to be utilized in ascertaining TRAEs."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Rucaparib Plus Ramucirumab With or Without Nivolumab in Advanced Gastric and Esophageal Adenocarcinoma

Anwaar Saeed 2020. "Rucaparib Plus Ramucirumab With or Without Nivolumab in Advanced Gastric and Esophageal Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03995017.

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