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Table 2 Trial treatment schedule

From: PRIMMO study protocol: a phase II study combining PD-1 blockade, radiation and immunomodulation to tackle cervical and uterine cancer

Drug Dose/Potency Frequency Time of oral intake Route of Administration Treatment Period Remarks
8 h 12 h 18 h 20 h
Pembrolizumab (Keytruda) 200 mg Q3W      IV infusion Day 1 of each 3-week cycle May be discontinued upon unacceptable toxicity
Administration should be withheld for drug-related non-hematologic toxicity ≥ grade 2 (excluding fatigue)
Use corticosteroids for irAE
Radiation 8 Gy 3 fractions 48 h apart       Day 1, 3 and 5 of Pembrolizumab cycle 1 See Additional file 1
Vitamin D3 (D-Cure) 2000 IU (50 μg) a Daily    X   Oral Daily from day −14 Intake of other vitamin D preparations should be stopped
Blood should be monitored for calcium and phosphate
Caution in patients receiving digitalis preparations
Lansoprazole (Lansoprazole Teva) 180 mg (uneven weeks);
30 mg (even weeks) b
Daily   X   X c Oral Daily from day −12 Needs to be taken at least 30 min before a meal
Patients taking any kind of proton pump inhibitors should switch to Lansoprazole Teva throughout the study period
Must be taken 2 h apart from all other orally administered drugs
Aspirin (Sedergine) 325 mg d Daily X     Oral Daily from day −11 Patients receiving any other anti-coagulant therapy should switch to Sedergine throughout the study
Cyclophosphamide (Endoxan) 50 mg e Daily X     Oral Daily from day −10 Monitor leukocyte levels regularly during treatment
Do not administer to patients with leukocyte levels < 2500/μl and/or thrombocyte levels of < 50,000/μl
Consumption of grapefruit and its derivatives is counter-advised
Curcumin (CurcuPhyt) (Food supplement, NIMP) 2 g f Daily X   X   Oral Daily from day −13 Patients are suggested to not take H2 Beta blockers (beta-adrenoreceptor antagonists)
Proton pump inhibitors should be consumed 2 h apart
Patients should not consume other turmeric containing food
  1. a30 drops should be resolved in fat-containing drink, e.g. milk
  2. b Capsules should be swallowed entirely with fluid
  3. c uneven weeks only
  4. d Effervescent tablets should be dissolved in water
  5. e Tablets should be taken with a large amount of fluid.
  6. f Capsules should be taken with a meal and not be chewed on