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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

Must not have

Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease

Clinically significant hematuria, hematemesis, or hemoptysis, or other history of significant bleeding within 12 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had skin cancer (not melanoma) treated and currently show no signs of it.

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I have not had significant bleeding or coughing up blood in the last 3 months.

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I have lung lesions or disease in my airways.

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I do not have active stomach or intestinal issues like ulcers or inflammation.

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My blood pressure is high despite taking medication.

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My cancer is growing into major blood vessels.

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I have been treated with PARP inhibitors before.

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I cannot swallow pills.

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I have been treated with PD1 or PD-L1 inhibitors before.

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My tumor is MSI high or MMR deficient.

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I do not have any serious ongoing illnesses like heart failure or severe infections.

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I have fluid buildup that can't be managed with treatment.

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My early-stage cancer was treated and shows no signs of disease.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (ORR)

Recommended Phase 2 Dose (RP2D)

Secondary study objectives

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

Neutrophil count decreased

Hypercholesterolaemia

Anxiety

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Nivolumab

2015

Completed Phase 3

~4010

Rucaparib

2016

Completed Phase 3

~2020