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Trial Risks

Possible known and unknown side effects

The known side effects and possible risks of this research study are:

VRP-HER2 Injections may cause some, all or none of the side effects listed below.

Minor side effects

  • Fever

  • chills

  • headache

  • Injection site reactions

Major side effects

  • allergic reactions with swelling in such places as your throat or lungs.  This could lead to shortness of breath, breathing failure or death. 

Medications that might be needed to treat allergic reactions include antihistamines such as diphenhydramine (Benadryl), epinephrine and corticosteroids.

Other medications may be given to make any side effects you experience less serious and uncomfortable.

Pembrolizumab injections may cause some, all or none of the side effects listed below.

Minor side effects

  • fatigue

  • cough

  • shortness of breath

  • nausea

  • itching

  • rash

  • loss of skin pigmentation

  • decreased appetite

  • headache

  • constipation

  • joint pain

  • back pain

  • diarrhea

Major side effects

  • lung problems including shortness of breath and/or chest pain

  • liver problems including nausea/vomiting, dark urine, bleeding/bruising more easily, yellowing of eyes or skin

  • kidney failure

  • changes in eyesight

  • severe muscle weakness

  • severe joint or muscle pains

  • infusion reactions including dizziness, fever, chills/shaking, itching

  • severe stomach area pain or tenderness

  • stool that are sticky/black or have blood or mucus

  • rapid heart beat

Additional Risks:

Your immune system could be stimulated to attack your own body (called autoimmunity), causing a low white blood cell count, which could lead to developing an infection, skin rash, joint swelling, intestinal inflammation (chronic colitis), or fluid around the heart and lungs. 

Because this is the first time AVX901 in combination with Pembrolizumab has been given to humans, there may be risks, discomforts, drug interactions or side effects that are not yet known. 

Some side effects may occur that do not need medical attention and may go away during treatment as your body adjusts.  Others may be severe and need immediate attention or lead to hospitalization.  Seek emergency care and contact your doctor immediately if severe side effects occur.


For more information about risks and side effects, ask your doctor. 

Administration of AVX901 and/or Pembrolizumab with any other HER-2 targeted therapies is investigational and the possible risks and side effects of combining the study drug with these therapies are unknown. 

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